White House Makes a Big Deal of New Heroin Efforts--But Says Nothing about Stemming the Flow or Why We're Still at War in Narco-State Afghanistan

On March 29, 2016 the White House issued a press release on its new heroin initiative.  The Washington Post described how much Obama proposed to do.  The long list of fixes and new public-private partnerships address addiction treatment almost exclusively, with a sop to law enforcement.  The 1 billion dollars spent, Obama said, will treat "tens of thousands" of addicts.  

Additional treatment is desperately needed, but the money won't go far.  The White House and RAND said in 2014 that the US had 800,000--2.4 million heroin addicts. Treatment requires many months or years, and costs tens of thousands of dollars per person. The new funding will support less than 10% of those needing treatment.

Speaking at the National Prescription Drug Abuse and Heroin Summit in Atlanta, Obama ... called addiction a “heartbreaking” issue that’s costing lives and devastating communities across the country.

But he said: “I’m very optimistic that we can solve it.”

Yeah right.  Till you get it off the street, bro, you ain't done shit.

And can you be as glib, Mr. President, at explaining why you completely left out efforts to reduce the heroin supply? 

From Wired, we learn that Obama ended (yes, ended) Afghan opium eradication soon after taking office:

In 2009, in one of his first major war policy decisions since becoming president, Barack Obama oversaw an end to U.S. poppy eradication... Without American support, Afghan government counternarcotic operations withered to a merely symbolic scale. Kabul’s agents would raze one acre of a 10-acre plot and call it “eradicated.”

And that's when the US heroin epidemic really took off, according to the National Institute on Drug Abuse:

Aerial poppy eradication is off the table, according to the State Department, and the US no longer supports Afghan national counter-narcotics efforts. Hello?

Mr. President:  Please explain why you pulled the wool over the eyes of the American people by claiming the Taliban are the profiteers of Afghan opium?  Why didn't you tell the truth: that they tax the acreage used to grow the crop?  (As do anti-Taliban militias in areas they control.) This is akin to property taxes.

Somebody else actually buys the opium, converts it to heroin, and brings it to the US, where it sells for over 1,000 times what the Taliban received in taxes.

Who, Mr. President, collects the big money?  Who buys the opium harvest, protects the movement of opium, its conversion to heroin, and ships it over here, undetected? Last I heard, the US installed much of the Afghan government and patrolled a lot of poppy fields.  Afghanistan is where between 75% and 93% of the world's illicit opium is grown each year, on 500,000 (undisturbed) acres.  

Funny how after spending 100 billion dollars on Afghan reconstruction, over $8 billion on opium eradication, and several trillion dollars on our 15 year Afghan war, the acreage under poppies has only expanded.  Funny about that. 

Funny, too, is that big question mark... why are we still in Afghanistan?  I thought we went to get Bin Laden.  Well, he's history.  

Can someone explain our military objective for Afghanistan?  How do we justify this longest war in the 240 year history of our nation? 

Writing about the Afghanistan war in National Defense magazine in 2009, Lawrence P. Farrell noted, 

"Seldom do we hear or read a discussion of what the “political objective” should be or even whether anyone has articulated the political aims for the use of military force in that country."

In 2010 General Petraeus was interviewed for the Council on Foreign Relations about this. He claimed, 

"our military's operational objective [was] nation-building, euphemistically called counterinsurgency..." 

Nation-building?  Back during the Vietnam war, we used a different expression to say the same thing:  “We had to destroy the village in order to save it.”  During the Vietnam war, most US heroin came from an area adjacent to Vietnam, the Golden Triangle.

Some of this heroin arrived in the US on military planes, according to the NY Times,  inside the body bags of fallen soldiers. It was loaded onto aircraft at US military bases in Vietnam, and unloaded at military bases in the US. Somebody in the US government knew what was going on.

At fourteen years into the Afghan war, in October 2015, USA Today reported, 

"The president said he does not believe in "endless war," but there remains an opportunity to forge a stable country that can prevent the emergence of future threats, an effort in which more than 2,200 Americans have given their lives."

Let's face it.  The explanations given by our leaders for our continuing adventure in Afghanistan are smoke and mirrors, nothing more.

Vietnam was an earlier war in which the number of US soldiers who had lost their lives was oft-repeated as justification to keep the war going. Vietnam was another war with fuzzy objectives, supposedly fought for a discredited "Domino Theory." But perhaps there are good reasons why the lessons of Vietnam seem to have been ignored. 

Few people know that Afghanistan hides immense underground wealth. But first it must be wrested from the Afghans. Heroin aside, two financial blockbusters are just waiting to be tapped.

1.  The value of Afghanistan's mineral wealth was estimated at one trillion dollars by NPR, and at 1-3 trillion dollars by Bloomberg.  This almost certainly influenced Russia's decade-long, failed invasion of Afghanistan throughout the 1980s.

"Afghanistan, with certainty I can say, in 20 years is going to be a mining country," Paul Brinkley, head of a Pentagon group called the Task Force for Business Stability Operations, tells NPR's Rachel Martin. "That is going to happen."

And from LiveScience in 2014:

Over the past four years, the US Geological Survey and Department of Defense's Task Force for Business and Stability Operations have embarked on dozens of excursions in the [Afghan] war zone to collect and analyze mineral samples...

The researchers' work has helped develop what are essentially treasure maps that let mining companies know what minerals are there, how much is there, and where they are, all to attract bids on the rights to the deposits...

Oilprice.com estimates that 59 trillion (with a T) cubic feet of natural gas are hidden underground in Afghanistan. 

2.   Pipeline construction, which has been on the table for the last 20 plus years, would move oil and gas from the Caspian basin to the Arabian Sea.  The region's proven gas and oil reserves (mainly in Turkmenistan and Kazakhstan, with some gas reserves in Afghanistan) are huge, and equal to those in the US.  To feasibly reach the ocean for transport via tankers, oil and gas pipelines from the Caspian region must cross through Afghanistan, or else through Iran. 

Conceivably, desire to access Caspian oil and gas, coupled with US military failure to gain control of required territory in Afghanistan, has led the Obama administration to begin normalizing relations with Iran, recently.

Proposed Central Asian Gas Pipelines
Source: Canadian Centre for Policy Alternatives, 2010.

(the proposed locations of pipelines may have shifted since 2010--Nass)

From The Diplomat comes a telling quote:

"It is, therefore, little surprise that some experts contend that the country is not transitioning from “war to peace,” but rather from “military conflict to resource conflict.'” 

Here's the thing.  Obama needs to "forge a stable country" to prevent pipelines from being tapped or blown up, and protect future mining operations.  No wonder retired Colonel Lawrence Wilkerson, who served as Secretary of State Colin Powell's chief of staff, predicted we will be in Afghanistan for another 50 years, in a stunning interview.

3.  Don't forget that Afghanistan's half million acres of poppy fields generate heroin worth roughly $200 billion dollars on the street, year after year. Unlike minerals and gas, this is a truly renewable resource.

Is the Afghan war--the longest American war--just about opium, minerals and pipelines? I could be missing some of the picture. Maybe I have oversimplified things. But phenomenal resources, still untapped, have to count as the lurking, almost-never-discussed elephant in the Afghan war room.

If the US government had reasonable political and military objectives, wouldn't the government have provided a coherent account of its objectives by now?  In the absence of any meaningful explanation for this war, the only reason we remain there, with no prospect of getting out, is to secure control of Afghanistan's resources for the US.  Or, more correctly, for the oligarchs who control US policy and who will reap the benefits--while the people of the US (and Afghanistan, much more so) pay the costs.

FACT:  The land under poppy cultivation (and opium production) has tripled since the US entered Afghanistan in 2001, helped by US spending for wells, roads and "reconstruction."

FACT:  Ground was broken for Afghanistan's first gas pipeline, TAPI, in December 2015, though it still needs investors. It is in part a joint venture between Turkmenistan, Afghanistan, Pakistan and India, thus the name TAPI. Presumably the militaries of all these countries can be enlisted to protect the pipeline. And presumably, private pipeline projects will remain on hold until their security can be guaranteed by US taxpayers.

Connect the dots.  As pipeline projects expand, as the number of mines increases, as Afghanistan retains its role as the world's #1 heroin-producing nation, so will our military presence remain, and grow.

But there is one small bright spot.  It is a Presidential election year, and the candidates do have to answer questions.  Can the Presidential candidates explain what we are doing in Afghanistan. Who owns Afghan mineral rights?  Who is invested in Afghan pipelines?

Will the next President change course, and get seriously behind drug interdiction and eradication in Afghanistan?  How will the US government get Afghan (and all) heroin off our streets? How many soldiers must continue to die to protect the right to loot Afghanistan? 

The huge tide of addiction blows right back from our rapacious Afghan policy. Over 10,000 Americans were lost to heroin in 2014. Deaths continue to climb.  In my state, Maine, deaths from heroin surpassed deaths from prescription drugs, for the first time, in 2015. 

Even children of the rich and powerful are being fed to the demon heroin. Like the plant in "Little Shop of Horrors" the more people this epidemic consumes, the bigger it gets. Will the costs of our Afghan policy ever become too high for our policymakers to bear?

--------------

The 2 earlier pieces I wrote regarding the heroin epidemic are here and here and they add to these ideas and documentation.  My mentors in this effort are Peter Dale Scott, Alfred McCoy, Michel Chossudovsky and Sibel Edmonds. Thanks also to William Edstrom for reminding me we can fight back.

Read more here: http://www.mcclatchydc.com/news/nation-world/national/article68892062.html#storyli

Read more here: http://www.mcclatchydc.com/news/nation-world/national/article68892062.html#storylink=cp

7 million Americans at risk from manmade earthquakes due to fracking / WaPo

Why is oil so cheap these days?  Maybe part of the answer is that the US government absolutely had to stop fracking-- because it finally admitted the resulting earthquakes could not be tolerated, nor could the poisoned water be ignored any longer. Like so much else in our modern USA, the profits derived from fracking were privatized, while the destruction it rained down got socialized (i.e., experienced, and later to be paid for by us all).  

Likely the collapse of the price of oil simplified things greatly for our government:  no long-drawn-out legal battles over the public health and environmental effects. Fracking lost money, so it simply and quietly went away.  Few recriminations had to be faced over the fact the industry was given carte blanche by governments to pollute aquifers. Maybe Americans wouldn't connect the fracking sites to all the new earthquake activity.  But the WaPo isn't letting that happen. Here is the verbatim story:

U.S. Geological Survey map shows the potential for Americans to experience damage from natural or human-induced earthquakes in 2016. Changes range from less than 1 percent to 12 percent. (Courtesy of USGS)

Earthquakes are a natural hazard — except when they're man-made. The oil and gas industry has aggressively adopted the technique known as hydraulic fracturing, or fracking, to shatter subsurface shale rock and liberate the oil and gas lurking there. But the process results in tremendous amounts of chemical-laden wastewater. Horizontal drilling for oil can also produce  massive amount of natural, unwanted salt water. The industry disposes of this wastewater by pumping it into deep wells.

And the Earth moves.

On Monday, the U.S. Geological Survey published for the first time an earthquake hazard map covering both natural and "induced" quakes. The map and an accompanying report indicate that parts of the central United States now face a ground-shaking hazard equal to the famously unstable terrain of California.

Some 7 million people live in places vulnerable to these induced tremors, the USGS concluded. The list of places at highest risk of man-made earthquakes includes Oklahoma, Kansas, Texas, Arkansas, Colorado, New Mexico, Ohio and Alabama. Most of these earthquakes are relatively small, in the range of magnitude 3, but some have been more powerful, including a magnitude 5.6 earthquake in 2011 in Oklahoma that was linked to wastewater injection.

Scientists said Monday they do not know if there is an upper limit on the magnitude of induced earthquakes; this is an area of active research. Oklahoma has had prehistoric earthquakes as powerful as magnitude 7.

USGS map displaying 21 areas impacted by induced earthquakes as well as the location of the fluid injection wells that have and have not been associated with earthquakes. (Courtesy of USGS)

It's not immediately clear whether this new research will change industry practices, or even whether it will surprise anyone in the areas of newly estimated risk. In Oklahoma, for example, the natural rate of earthquakes is only one or two a year, but there have been hundreds since fracking and horizontal drilling, with the associated wastewater injection, became commonplace in the last decade.

"By including human-induced events, our assessment of earthquake hazards has significantly increased in parts of the U.S.,” Mark Petersen, chief of the USGS National Seismic Hazard Mapping Project, said in a release.

The report, based on recent seismic activity, is just a one-year hazard assessment. In effect, the scientists have said that what has happened in the recent past with induced earthquakes will likely happen in the near future.

Past USGS hazard maps didn't include man-made events. The 2014 USGS seismic hazard map showed negligible risk of natural earthquakes in the Dallas-Fort Worth area, for example. But the new map, with the induced shaking added, boosts the risk there by a factor of 10, the USGS determined.

USGS map displaying 21 areas where scientists have observed rapid changes in seismicity that have been associated with wastewater injection. The map also shows earthquakes - both natural and induced - recorded from 1980 to 2015 in the central and eastern U.S. with a magnitude greater than or equal to 2.5. (Courtesy of USGS)

A fault running between Dallas and the adjacent city of Irving caused a magnitude 3.6 earthquake in January 2015. An injection well is only about six miles away. Researchers are actively studying that 2015 tremor, said Heather R. DeShon, a seismologist at Southern Methodist University.

“The new map serves as a reminder to the local populations living with the recent earthquakes that it is best to be prepared to feel ground shaking," said DeShon, who was not involved in the new study.

The Dallas Morning News reported that an unreleased study by the Federal Emergency Management Agency estimated that a worst-case, 5.6 magnitude earthquake hitting Dallas could damage 80,000 buildings, cause levees to collapse and lead to $9.5 billion in economic losses.

The most dramatic feature on the new USGS map is the dark red blob in north-central Oklahoma, which has already had a magnitude 5.1 earthquake this year.

"My first thought was actually holy crap, Oklahoma is redder than California," USGS geologist Susan Hough said in an email to The Post after she saw her agency's map Monday for the first time.

The earthquake hazard is hard to estimate in any given moment and in any given place, in part because natural earthquakes are inherently unpredictable. The oil and gas industry is unpredictable, too. With oil prices low, companies have cut back on drilling recently.

The cut-back in production may be one explanation for a decline in recent months in earthquakes in southern Kansas, said Rex Buchanan, director of the Kansas Geological Survey. Another factor may be new state regulations governing the wastewater disposal wells, he said.

With a few exceptions, locations in the nation's central and eastern regions are not generally thought of as seismically active. But that doesn't mean there aren't faults underlying those calmer regions. “Pretty much everywhere has faults. The nation was built over a billion years, and lots and lots of faults are left over from the construction process," Michael Blanpied, associate coordinator of the USGS Earthquake Hazards Program, told The Post.

The fluids injected into the deep wells don't lubricate the faults so much as put additional pressure on them, driving their walls apart, he noted.

In Syria, militias armed by the Pentagon fight those armed by the CIA/ LA Times

Can you be sickened any more by the us role in Syria?  how many sides has the us government supplied?  how much must the syrian people pay for our recklessness?  

how many us troops are shooting at each other in syria?

Below is verbatim from the March 27 Los Angeles times:  read it and weep.

Syrian militias armed by different parts of the U.S. war machine have begun to fight each other on the plains between the besieged city of Aleppo and the Turkish border, highlighting how little control U.S. intelligence officers and military planners have over the groups they have financed and trained in the bitter five-year-old civil war.

The fighting has intensified over the last two months, as CIA-armed units and Pentagon-armed ones have repeatedly shot at each other while maneuvering through contested territory on the northern outskirts of Aleppo, U.S. officials and rebel leaders have confirmed.

In mid-February, a CIA-armed militia called Fursan al Haq, or Knights of Righteousness, was run out of the town of Marea, about 20 miles north of Aleppo, by Pentagon-backed Syrian Democratic Forces moving in from Kurdish-controlled areas to the east.

 “Any faction that attacks us, regardless from where it gets its support, we will fight it,” Maj. Fares Bayoush, a leader of Fursan al Haq, said in an interview.

Rebel fighters described similar clashes in the town of Azaz, a key transit point for fighters and supplies between Aleppo and the Turkish border, and on March 3 in the Aleppo neighborhood of Sheikh Maqsud.

The attacks by one U.S.-backed group against another come amid continued heavy fighting in Syria and illustrate the difficulty facing U.S. efforts to coordinate among dozens of armed groups that are trying to overthrow the government of President Bashar Assad, fight the Islamic State militant group and battle one another all at the same time.

“It is an enormous challenge,” said Rep. Adam Schiff (D-Burbank), the top Democrat on the House Intelligence Committee, who described the clashes between U.S.-supported groups as “a fairly new phenomenon.”

“It is part of the three-dimensional chess that is the Syrian battlefield,” he said.

The area in northern Syria around Aleppo, the country's second-largest city, features not only a war between the Assad government and its opponents, but also periodic battles against Islamic State militants, who control much of eastern Syria and also some territory to the northwest of the city, and long-standing tensions among the ethnic groups that inhabit the area, Arabs, Kurds and Turkmen.

“This is a complicated, multi-sided war where our options are severely limited,” said a U.S. official, who wasn't authorized to speak publicly on the matter. “We know we need a partner on the ground. We can't defeat ISIL without that part of the equation, so we keep trying to forge those relationships.”

ISIL is an acronym for Islamic State. President Obama this month authorized a new Pentagon plan to train and arm Syrian rebel fighters, relaunching a program that was suspended in the fall after a string of embarrassing setbacks which included recruits being ambushed and handing over much of their U.S.-issued ammunition and trucks to an Al Qaeda affiliate.

Amid the setbacks, the Pentagon late last year deployed about 50 special operations forces to Kurdish-held areas in northeastern Syria to better coordinate with local militias and help ensure U.S.-backed rebel groups aren't fighting one another. But such skirmishes have become routine.

Last year, the Pentagon helped create a new military coalition, the Syrian Democratic Forces. The goal was to arm the group and prepare it to take territory away from the Islamic State in eastern Syria and to provide information for U.S. airstrikes.

The group is dominated by Kurdish outfits known as People's Protection Units or YPG. A few Arab units have joined the force in order to prevent it from looking like an invading Kurdish army, and it has received air-drops of weapons and supplies and assistance from U.S. Special Forces.

Gen. Joseph Votel, now commander of U.S. Special Operations Command and the incoming head of Central Command, said this month that about 80% of the fighters in the Syrian Democratic Forces were Kurdish. The U.S. backing for a heavily Kurdish armed force has been a point of tension with the Turkish government, which has a long history of crushing Kurdish rebellions and doesn't want to see Kurdish units control more of its southern border.

The CIA, meanwhile, has its own operations center inside Turkey from which it has been directing aid to rebel groups in Syria, providing them with TOW antitank missiles from Saudi Arabian weapons stockpiles.

While the Pentagon's actions are part of an overt effort by the U.S. and its allies against Islamic State, the CIA's backing of militias is part of a separate covert U.S. effort aimed at keeping pressure on the Assad government in hopes of prodding the Syrian leader to the negotiating table.

At first, the two different sets of fighters were primarily operating in widely separated areas of Syria — the Pentagon-backed Syrian Democratic Forces in the northeastern part of the country and the CIA-backed groups farther west. But over the last several months, Russian airstrikes against anti-Assad fighters in northwestern Syria have weakened them. That created an opening which allowed the Kurdish-led groups to expand their zone of control to the outskirts of Aleppo, bringing them into more frequent conflict with the CIA-backed outfits.

“Fighting over territory in Aleppo demonstrates how difficult it is for the U.S. to manage these really localized and in some cases entrenched conflicts,” said Nicholas A. Heras, an expert on the Syrian civil war at the Center for a New American Security, a think tank in Washington. “Preventing clashes is one of the constant topics in the joint operations room with Turkey.”

Over the course of the Syrian civil war, the town of Marea has been on the front line of Islamic State's attempts to advance across Aleppo province toward the rest of northern Syria.

On Feb. 18, the Syrian Democratic Forces attacked the town. A fighter with the Suqour Al-Jabal brigade, a group with links to the CIA, said intelligence officers of the U.S.-led coalition fighting Islamic State know their group has clashed with the Pentagon-trained militias.

“The MOM knows we fight them,” he said, referring to the joint operations center in southern Turkey, using an abbreviation for its name in Turkish, Musterek Operasyon Merkezi. “We'll fight all who aim to divide Syria or harm its people.” The fighter spoke on condition of anonymity.

Marea is home to many of the original Islamist fighters who took up arms against Assad during the Arab Spring in 2011. It has long been a crucial way station for supplies and fighters coming from Turkey into Aleppo.

“Attempts by Syrian Democratic Forces to take Marea was a great betrayal and was viewed as a further example of a Kurdish conspiracy to force them from Arab and Turkmen lands,” Heras said.

The clashes brought the U.S. and Turkish officials to “loggerheads,” he added. After diplomatic pressure from the U.S., the militia withdrew to the outskirts of the town as a sign of good faith, he said.

But continued fighting among different U.S.-backed groups may be inevitable, experts on the region said.

“Once they cross the border into Syria, you lose a substantial amount of control or ability to control their actions,” Jeffrey White, a former Defense Intelligence Agency official, said in a telephone interview. “You certainly have the potential for it becoming a larger problem as people fight for territory and control of the northern border area in Aleppo.”

Bulos is a special correspondent.

“Evidence-based medicine has been hijacked:” A confession from John Ioannidis/ Retraction Watch

An interview with my favorite scientist, Dr John Ioannidis (excerpts below), discusses the problem of bogus medical and scientific findings, which are now ubiquitous-- as the standards are low and the funders have come to view many of the studies they fund as marketing.

John Ioannidis is perhaps best known for a 2005 paper “Why Most Published Research Findings Are False.” One of the most highly cited researchers in the world, Ioannidis, a professor at Stanford, has built a career in the field of meta-research. Earlier this month, he published a heartfelt and provocative essay in the the Journal of Clinical Epidemiology titled “Evidence-Based Medicine Has Been Hijacked: A Report to David Sackett.” In it, he carries on a conversation begun in 2004 with Sackett, who died last May and was widely considered the father of evidence-based medicine. We asked Ioannidis to expand on his comments in the essay, including why he believes he is a “failure.” 

Retraction Watch: You write that as evidence-based medicine “became more influential, it was also hijacked to serve agendas different from what it originally aimed for.” Can you elaborate? 

John Ioannidis: As I describe in the paper, “evidence-based medicine” has become a very common term that is misused and abused by eminence-based experts and conflicted stakeholders who want to support their views and their products, without caring much about the integrity, transparency, and unbiasedness of science. 

RW: You also write that evidence-based medicine “still remains an unmet goal, worthy to be attained.” Can you explain further? 

JI: The commentary that I wrote gives a personal confession perspective on whether evidence-based medicine currently fulfills the wonderful definition that David Sackett came up with: “integrating individual clinical expertise with the best external evidence”. This is a goal that is clearly worthy to be attained, but, in my view, I don’t see that this has happened yet. Each of us may ponder whether the goal has been attained. I suspect that many/most will agree that we still have a lot of work to do. 

RW: You write that clinical evidence is “becoming an industry advertisement tool” and that “much ‘basic’ science [is] becoming an annex to Las Vegas casinos.” Provocative — what do you mean? 

JI: Since clinical research that can generate useful clinical evidence has fallen off the radar screen of many/most public funders, it is largely left up to the industry to support it.  The sales and marketing departments in most companies are more powerful than their R&D departments. Hence, the design, conduct, reporting, and dissemination of this clinical evidence becomes an advertisement tool. As for “basic” research, as I explain in the paper, the current system favors PIs who make a primary focus of their career how to absorb more money. Success in obtaining (more) funding in a fiercely competitive world is what counts the most. Given that much “basic” research is justifiably unpredictable in terms of its yield, we are encouraging aggressive gamblers. Unfortunately, it is not gambling for getting major, high-risk discoveries (which would have been nice), it is gambling for simply getting more money. 

RW: Studying what ails science doesn’t make you popular with other researchers — until they want to publish with you, of course, as you point out in your piece. But those criticisms can also lump you in with those that you describe as “pseudo-scientists and dogmatists…trying to exploit individuals and populations and attack science.” How do you differentiate your own work? 

JI: I definitely can’t complain for lack of popularity. I feel privileged to have worked with thousands of other scientists over the years and to have learnt from them. It is not possible to make everybody happy all the time, but the work of my team is aiming to protect science, defend the scientific method, question dogma, and enhance the capability and efficiency of research methodology and research practices.  In this regard, it is at the very opposite pole than those who want to attack science, question the scientific method and promote dogmas. 

RW: You’re worried that Cochrane Collaboration reviews — the apex of evidence-based medicine — “may cause harm by giving credibility to biased studies of vested interests through otherwise respected systematic reviews.” Why, and what’s the alternative? 

JI: A systematic review that combines biased pieces of evidence may unfortunately give another seal of authority to that biased evidence. Systematic reviews may sometimes be most helpful if, instead of focusing on the summary of the evidence, highlight the biases that are involved and what needs to be done to remedy the state-of-the-evidence in the given field. This often requires a bird’s eye view where hundreds and thousands of systematic reviews and meta-analyses are examined, because then the patterns of bias are much easier to discern as they apply across diverse topics in the same or multiple disciplines. Much of the time, the solution is that, instead of waiting to piece together fragments of biased evidence retrospectively after the fact, one needs to act pre-emptively and make sure that the evidence to be produced will be clinically meaningful and unbiased, to the extent possible. Meta-analyses should become primary research, where studies are designed with the explicit anticipation that they are part of an overarching planned cumulative meta-analysis. 

RW: What are your hopes for evidence-based medicine moving forward? 

JI: The right ideas are there, and there are many superb scientists and clinicians who want to do the right thing, so I am always cautiously hopeful. We should keep trying.

Risky Drugs: Why the FDA Cannot Be Trusted/ Safra Center for Ethics, Harvard

Here is the first half of a wonderful piece by Professor Donald Light on the mess at FDA, which misguides the process of drug evaluation and approval.  The entire piece can be found here:

A forthcoming article for the special issue of the Journal of Law, Medicine and Ethics (JLME), edited by Marc Rodwin and supported by the Edmond J. Safra Center for Ethics, presents evidence that about 90 percent of all new drugs approved by the FDA over the past 30 years are little or no more effective for patients than existing drugs.  

All of them may be better than indirect measures or placebos, but most are no better for patients than previous drugs approved as better against these measures. The few superior drugs make important contributions to the growing medicine chest of effective drugs.  The bar for “safe” is equally low, and over the past 30 years, approved drugs have caused an epidemic of harmful side effects, even when properly prescribed. 

Every week, about 53,000 excess hospitalizations and about 2400 excess deaths occur in the United States among people taking properly prescribed drugs to be healthier. One in every five drugs approved ends up causing serious harm,1 while one in ten provide substantial benefit compared to existing, established drugs. This is the opposite of what people want or expect from the FDA.   

Prescription drugs are the 4th leading cause of death. Deaths and hospitalizations from over-dosing, errors, or recreational drug use would increase this total. American patients also suffer from about 80 million mild side effects a year, such as aches and pains, digestive discomforts, sleepiness or mild dizziness.  The forthcoming article in JLME also presents systematic, quantitative evidence that since the industry started making large contributions to the FDA for reviewing its drugs, as it makes large contributions to Congressmen who have promoted this substitution for publicly funded regulation, the FDA has sped up the review process with the result that drugs approved are significantly more likely to cause serious harm, hospitalizations, and deaths. 

New FDA policies are likely to increase the epidemic of harms. This will increase costs for insurers but increase revenues for providers.  This evidence indicates why we can no longer trust the FDA to carry out its historic mission to protect the public from harmful and ineffective drugs. Strong public demand that government “do something” about periodic drug disasters has played a central role in developing the FDA.2Yet close, constant contact by companies with FDA staff and officials has contributed to vague, minimal criteria of what “safe” and “effective” mean. 

The FDA routinely approves scores of new minor variations each year, with minimal evidence about risks of harm. Then very effective mass marketing takes over, and the FDA devotes only a small percent of its budget to protect physicians or patients from receiving biased or untruthful information.34 The further corruption of medical knowledge through company-funded teams that craft the published literature to overstate benefits and understate harms, unmonitored by the FDA, leaves good physicians with corrupted knowledge.5 6 Patients are the innocent victims…  

Poor Tdap Effectiveness Against Pertussis in Adolescents/ Journal of Pediatrics

Growing numbers of yearly pertussis cases have been recorded over the past few years in the US:  more than at any time since 1959.  

Yet additional doses of the vaccine (for diptheria, tetanus and pertussis, or DTaP) have come to be recommended by CDC:

1.  Many states have added a booster dose in 7th grade
2.  3 years ago CDC recommended that women should be given a booster dose of vaccine in the middle of every pregnancy, even though the vaccine was not approved for pregnancy use. Notes the Boostrix DTaP package insert:

"Animal fertility studies have not been conducted with BOOSTRIX. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, BOOSTRIX should be given to a pregnant woman only if clearly needed." 

Essentially, very young babies are at serious risk from pertussis.  For most of the rest of us, the disease causes an annoying cough for about two months. So it might be reasonable, in principle, to vaccinate pregnant women to protect their neonates from the disease.  But is it reasonable to do so in the absence of animal fertility studies proving the vaccine is safe for the fetus?  That is reckless.

It became clear to anyone who looked that the pertussis vaccine wasn't working very well.  
Now, in the March issue of Pediatrics, a study from the huge Kaiser Permanente database confirms what we were seeing.

Waning Tdap Effectiveness in Adolescents

 Nicola Klein, et al.

RESULTS: On the basis of 1207 pertussis cases, Tdap VE during the first year after vaccination was 68.8% (95% confidence interval [CI] 59.7% to 75.9%), decreasing to 8.9% (95% CI –30.6% to 36.4%) by ≥4 years after vaccination. Adolescents who were more remote from Tdap were significantly more likely to test positive for pertussis than were those vaccinated more recently (HR per year 1.35, 95% CI 1.22 to 1.50).CONCLUSIONS: Routine Tdap did not prevent pertussis outbreaks. Among adolescents who have only received DTaP vaccines in childhood, Tdap provided moderate protection against pertussis during the first year and then waned rapidly so that little protection remained 2-3 years after vaccination.