Tuesday, November 8, 2016

Who's Fooling Who? CDC Says Most Overdose Deaths Involve a Prescription Opioid. But in Massachusetts Only 20% do.

Drug overdose deaths in the United States hit record numbers in 2014

 At least half of all opioid overdose deaths involve a prescription opioid. HHS/CDCMore people died from drug overdoses in 2014 than in any year on record. The majority of drug overdose deaths (more than six out of ten) involve an opioid.1 And since 1999, the number of overdose deaths involving opioids (including prescription opioid pain relieversand heroin) nearly quadrupled.2 From 2000 to 2014 nearly half a million people died from drug overdoses. 78 Americans die every day from an opioid overdose.
We now know that overdoses from prescription opioid pain relievers are a driving factor in the 15-year increase in opioid overdose deaths. Since 1999, the amount of prescription opioids sold in the U.S. nearly quadrupled,2 yet there has not been an overall change in the amount of pain that Americans report.3,4 Deaths from prescription opioids—drugs like oxycodone, hydrocodone, and methadone—have also quadrupled since 1999.5

In Massachusetts, real time data have just been made available, and fentanyl and heroin overdose deaths outweigh those involving prescription opioids 4 to 1 and 3 to 1, respectively. Prescription opioids were only found in 20% of OD deaths.

Afghanistan had a bumper crop of opium this year, while illicit fentanyl consumption and production (which, unlike heroin, does not require opium as a raw material, and its potential production is virtually limitless) is also booming.  

Why does CDC blow smoke about the narcotic crisis?

Tuesday, November 1, 2016

She didn’t think a flu shot was necessary — until her daughter died/ WaPo

Last week's Washington Post had a very sad, haunting story about the death of a twelve year old girl from flu-related causes.  Her mother had tried for ten years to have her, and finally succeeded using in vitro fertilization.  Then her daughter developed flu, organ failure and died, in rapid succession, last January.

It was probably no coincidence the story was published in October, the prime month for advertisements for flu shots.  While the take home message was to get your children vaccinated, the odds that a vaccine would have prevented this death are less than even. 

My comment:

This story omitted important information. 
According to CDC, the flu shot has been, on average, 37% effective over the past 12 years. However, also according to CDC, the FluMist nasal vaccine used in children was pulled this year, because it *did not work* over the past 3 flu seasons. 

According to the Cochrane Collaboration, there are no data on flu vaccine efficacy in infants and toddlers. Therefore I would not encourage parents of very young children to vaccinate them for flu, as the vaccine might be considered experimental in this age group. 

Last year there were 85 pediatric deaths from flu. There are 80 million flu vaccine-eligible children in the US. If you vaccinated 80,000,000, you might prevent an estimated 31 pediatric deaths (37% x 85)---but you would cause many cases of Guillain-Barre paralysis and other side effects. So the net cost/benefit of vaccinating children is uncertain, and could well be negative. 

Finally, nearly all people who die from flu-related causes die from a complication of flu, like pneumonia. In Piper Lowery's case, her mother took her to the hospital "several times" in the 4 days from illness onset to death. Why was she sent home several times? Her doctors should have known better. 

Sunday, October 30, 2016

My disappeared post, and important comment, recovered from the WayBackMachine, about how US heroin comes mostly from Afghanistan, not Mexico, and the US Government could easily stem the supply, if it wished to

Saturday, January 30, 2016

NY Times' penetrating look at the heroin epidemic gets the cause and solution all wrong

On October 30, 2015 the NY Times published an in-depth article on the heroin epidemic, focused on New Hampshire, which saw the greatest increase in deaths from drug overdoses (74%) in the US between 2013 and 2014.  New Hampshire is a bucolic place, where villages of tidy white capes and saltboxes lie sprinkled among the mountains and pine forests.

Manchester, New Hampshire's largest city, has a population of 110,000.  In one 6 hour period on September 24, Manchester police responded to 6 separate heroin overdoses. Manchester saw over 500 overdoses and over 60 deaths between January 1 and September 24, 2015.

At presidential campaign stops throughout the state, candidates were forced to respond to the problem when New Hampshire citizens demanded answers.  Hillary has a $10 billion dollar plan for prevention and treatment of abuse.  Chris Christie prefers treatment to jail time for first offenders. Obama announced a $5 million initiative in August to combat heroin addiction and trafficking. (Later he upped it to a billion.) New Hampshire has designated a drug czarNH Senator Ayotte says,"We've got to reduce the stigma."  Narcan, an opiate antidote that has been made widely available, is admittedly a band-aid.  It saves lives from acute overdoses, but does absolutely nothing to stem the tide of abuse.
The solutions being touted by politicians and the media include "working together:" police, citizens, and health-care facilities--though to what end is unclear; educating; reducing the stigma of heroin use (now that users are predominantly white and middle class we can relabel addiction a disease, not a crime); adding treatment facilities; and adding more police.

I call this salutary--but almost entirely missing the mark.  

Overdose deaths and heroin users are at an all time high in the United States. Between 2 and 9 of every thousand Americans (0.2-0.9% of the population) is currently using heroin. In Maine, 8% of babies are born "drug-affected"--a stratospheric rise from 178 babies in 2006 to 995 babies in fiscal 2015.  A NEJM study found opiate-addicted babies in neonatal ICUs quadrupled between 2006 and 2013. 

Despite what you have heard, the cause of our current heroin epidemic is not as simple as doctors over-prescribing narcotics, or users switching to heroin when prescription drugs became more scarce and expensive.
According to CDC itself, "CDC has programmatically characterized all opioid pain reliever deaths (natural and semisynthetic opioids, methadone, and other synthetic opioids) as 'prescription' opioid overdoses."  That means illegally produced or trafficked drugs, in these categories, are incorrectly being designated as prescription drugs. Further confusing the issue is that heroin is broken down to morphine in the body, which is a prescription drug. So, if fully metabolized at the time of autopsy, a death due to heroin may be labeled as due to a prescription drug. Fentanyl, a stronger (synthetic--no poppies needed) narcotic than heroin, is often used to "cut" heroin. While it may be a prescription drug, it is also illegally manufactured. Deaths due to fentanyl may be incorrectly classified as prescription overdoses. Also, many overdoses are due to simultaneous use of multiple drugs, so identifying the drug that caused death may be impossible.

The implication is that some iv heroin deaths are being misclassified as due to legal drugs, and the 10,500 heroin overdose deaths recorded in 2014 may be a gross underestimate.

The undeniable root cause of the current heroin epidemic is a massive increase in availability
--huge amounts of relatively cheap heroin have been flooding into the US in the last few years, exceeding what can be sold in our large cities, and now finding its way into even the tiniest hamlets. Without it, there would be no epidemic. The NY Times story failed to mention this.

Here's the problem with the NY Times' and the politicians' solutions:  neither fifty individual states nor thousands of towns and villages can treat, educate, exhort, investigate or imprison their way out of the heroin maelstrom, while the next fix is cheap and just around the corner. There are nowhere near enough social workers, foster parents, police, prisons, treatment facilities or sources of funding to handle the numbers affected.  Narcan and clean needles don't cut the mustard. And most active addicts don't want to be treated, coming to treatment only when pushed by the legal system.

There is only one possible solution, and that is stemming the supply.  Until this is understood, and acted on, the epidemic of heroin abuse will continue. 

In my September 7 blog post, I explained why 96% of US heroin does not come from Mexico and Colombia, as claimed by multiple US government agencies.  Mexican and Colombian production is inadequate to supply even half the US market.

At least Canada knows where its heroin comes from:  "According to the Royal Canadian Mounted Police National Intelligence Coordination Center, between 2009 and 2012 at least 90 per cent of the heroin seized in Canada originated in Afghanistan." (page 46)

If one wants to get into the weeds on this issue, a 2014 RAND report titled What America’s Users Spend on Illegal Drugs: 2000-2010 is a good place to start.  The  report, performed under contract for DHHS and released by the White House, looks at multiple databases and identifies many problematic issues with estimates of heroin country-of-origin.

It shows that while Colombian opium was allegedly supplying 50% of a growing US heroin market between 2001 and 2010 (pages 82-83), Colombian production actually sank from 11 metric tons in 2001 to only 2 in 2009.

Furthermore, US government estimates for the 2000-2010 decade of Mexican production relied on a claimed 3 growing seasons per year, while in reality there were only 2. RAND admits Mexican production estimates by the US government were juiced: 
"The US government now recognizes that the previous estimates were inflated. There are no back-cast revised estimates (marijuana and poppy/heroin) for the whole country of Mexico prior to 2011."
Mexico historically produced lower quality, "black tar" heroin, used west of the Mississippi, while the influx of heroin to the US, and particularly in the eastern US, has been of higher quality white/tan powder. The DEA's 2015 National Heroin Threat Assessment notes, "Availability levels are highest in the Northeast" [that part of the continental US furthest from the Mexican border] "and in areas of the Midwest, according to law enforcement reporting," which would make no sense if the heroin originated in Mexico. In fact, the same report revealed that the Southwest US [the area adjacent to Mexico] had the lowest number of respondents of any US region (only 4.3%) who felt heroin was the greatest drug threat, compared to 63.4% of law enforcement respondents in New England.

Meanwhile, according to RAND"in recent years, there have been no [heroin] seizures or purchases from Southeast Asia [Myanmar, Laos, Thailand] by DEA's Domestic Monitoring Program."

Back in 1992, DEA estimated that 32% of US heroin came from Southwest Asia (mainly Afghanistan). Since then, Afghan opium production has tripled. But in the years 1994 through 2010 only 1-6% of US heroin had a Southwest Asian origin, according to DEA's Domestic Monitoring Program. Yet Afghan production accounts for 85-90% of the world heroin supply. 

It would be great if we could point to improved US interdiction at the source, or to poppy field eradication to explain this anomaly.  But neither is the case. Seizures of heroin in Afghanistan dropped from 27 metric tons in 2010  to 8 metric tons in 2013, according to the UN, figure 41. Only 1.2% of Afghan poppy fields were eradicated in 2014, also according to the UN.

The UN Office on Drugs and Crime 2013 Report acknowledges that US estimates of where its heroin comes from (claiming about 50% comes from Colombia) make no sense:
"Continued inconsistency in the information available from the Americas on opiate production and flows makes an analysis of the situation difficult – while Mexico has the greater potential production of opium, it is Colombia that is reported as the main supplier of heroin to the United States. The Canadian market seems to be supplied by producers from Asia." (page 30) 
"It is unclear how Colombia, given its much lower potential production, could supply larger amounts to the United States market than Mexico." (page 37)
It is undeniable:  there has been profound, systematic deception by the US government to inflate estimates of the amount of heroin coming from Mexico and Colombia, presumably to conceal the actual origin of most US heroin, and possibly to protect its means of entry into the US.

We know where and how to look for heroin. Afghanistan and Myanmar are the world's #1 and #2 producers, accounting for over 95% of world production.   Historically, most heroin bound for the US left these countries by air. There are a manageable number of flights departing Afghanistan and Myanmar.  We could put all the needed personnel in place, today, to fully inspect every flight and every airport.

The fact that we have looked the other way and pointed in the wrong direction is itself the smoking gun.

UPDATE: In June 2016 the Drug Enforcement Agency confirmed what I said about methodologic issues leading to underestimates of heroin deaths (page 10):

"Heroin deaths are often undercounted because of variations in state reporting procedures, and because heroin metabolizes into morphine very quickly in the body, making it difficult to determine the presence of heroin. Many medical examiners are reluctant to characterize a death as heroin-related without the presence of 6-monoaceytlmorphine (6-MAM), a metabolite unique to heroin, but which quickly metabolizes into morphine.11 Thus many heroin deaths are reported as morphine-related deaths. Further, there is no standardized system for reporting drug-related deaths in the United States. The manner of collecting and reporting death data varies with each medical examiner and coroner.12 "

The comment below was made to a cross-posting of my article on the Global Research Facebook page, and speaks to trafficking heroin from Afghanistan to the US--Meryl Nass

Hold on, folks. Don't be so hasty. [He is responding to a
prior comment blaming the military for the heroin trafficking.]

As a veteran who served in Afghanistan, I can tell you that the military
involvement is limited and knowledge/awareness even more so. The CIA and
contractors are running unmarked cargo aircraft out of our airbases at
Bagram and Kandahar. Yes, Air Force personnel load the shrink-wrapped
palates onto the planes, but they don't know what's inside.

For those of you who doubt that, let's recall the case of Ciara Durkin.
Ciara was a Massachusetts National Guardsman who died "under mysterious
circumstances" from a rifle bullet to her head at Bagram. Details reveal
that her death was not suicide, as some may be quick to suspect: She was
shot from a distance as she left the base chapel. She worked in finance and
had recently wrote a letter to her family that she "uncovered something."
That was in 2007.

Let's not forget Pat Tillman. He was killed in 2004, right before I left
the country. A member of the Army Rangers, his unit was working extensively
in the opium territory along the Pakistani border. While everyone has heard
that his death was officially ruled "friendly fire," what most don't know
is that he had undergone a change of heart while serving in
Afghanistan--out of FOB Salerno, where I spent my 30th birthday. A man of
conscience, he could have been swayed by the racism, prejudice, and general
de-humanization the US military had affected toward the Afghani people. Or,
he could have taken issue with the fact that the official policy towards
all military personnel was "hands-off" of the opium fields. He was
certainly in position to do so. Whichever was the case, we'll never know.

It is the CIA that is primarily responsible for the clearance of targets
for military operations . . . and of aircraft allowed to enter/leave the
Afghani airspace. The military--all branches--merely comply with the
orders, authorizations, or restrictions handed down.

And let's not forget that many of our military are themselves having
changes of heart, awakenings of conscience, or whatever you want to call
it. They are disheartened and disillusioned about the occupation--its goals
and intentions. They are stuck, however, and unable to change anything,
protest, question, or even disobey without facing court marshal or
fratricide. This is why so many end up depressed, turn to drugs themselves,
or commit suicide. They see the unmarked planes being loaded. They are told
to "look the other way," or "you don't see anything," or "that plane
doesn't exist." But they do see them and they know they exist . . . and are
powerless to do anything about it.

No, please, don't blame the military. Blame the CIA. Blame the civilian
contractors. It's Air America all over again. First it was a geopolitical
strategy to divert a major source of revenue for Iran, but then it surely
took on a life of its own when they realized how much money they could
bring in by controlling the world's heroin supply. And so they have. And
with such an undocumented and unlimited supply of money, they don't care
about Congress or even the POTUS. With all of the destabilization
operations, Color Revolutions, and direct support for IS, it would seem
that they've gone rogue. God help us all! 

Saturday, October 22, 2016

Corrupt Government Officials are America's Biggest Fear/ Chapman University Poll

Government Corruption beats Terrorism and Fears of Economic Collapse by a mile.  Little wonder, with two presidential candidates who each have crooked foundations (used at a minimum for money-laundering and apparent foreign policy 'quid pro quo's' for the Clinton Foundation).  Hillary stole White House furniture and gifts when she left in 2000, while Trump used donations to his foundation to get a life-size portrait of himself painted.  Trump used bankruptcies to avoid paying his creditors. Hillary blamed a 12 year old for her own rape, successfully defending the rapist, whom she knew was guilty.

These two low lifes do deserve an award of some kind.  How about:  "The person I would least want to house sit for me"?  Or "the most likely to succeed in covering their own or their spouses' sexual assaults"?

Maybe "Tops at stealing under the guise of a philanthropic foundation"?

Please, America, give them their awards.  Make them big, shiny, and definitely gold-plated. Then arrest these two clowns for their many crimes, remind them that felons can't be president or even vote, and let's reset the election season for 2017.

Or just elect Jill Stein for President, who is running as the Green Party candidate.  She tells the truth, she is smart (degrees from Harvard and Harvard Med School), has absolutely no taint of corruption, says what she means without asking a focus group, and cares about the country and world.  She actually tells you her program, and its a very good one. What a novel candidate.

Tuesday, October 4, 2016

Sovaldi cured my Hep C but killed me by reactivating Hep B

FDA Adds Boxed Warning to Hepatitis C Drugs, Warns of Hepatitis B Reactivation Risk 

Posted 04 October 2016By Zachary Brennan
The US Food and Drug Administration (FDA) on Tuesday warned of serious risks for some patients who have been infected with the hepatitis B virus (HBV) and are being treated with certain direct-acting antiviral (DAA) medicines for hepatitis C virus (HCV).
FDA identified 24 cases of HBV reactivation reported to FDA and from the published literature in HCV/HBV co-infected patients treated with DAAs between 22 November 2013 and 18 July 2016. 
Of the cases reported, two patients died and one required a liver transplant, though FDA cautions that this number includes only cases submitted to FDA, so there are likely additional cases.
- See more at: http://www.raps.org/Regulatory-Focus/News/2016/10/04/25946/FDA-Adds-Boxed-Warning-to-Hepatitis-C-Drugs-Warns-of-Hepatitis-B-Reactivation-Risk/#sthash.BVELqNYl.dpuf

Friday, September 30, 2016

Healthcare deductible costs rose at 16x the rate of inflation since 2006/ NYT

A NYT editorial discussed healthcare costs last week using two simple graphs. In case you still have good insurance, take a look at what has happened to the rest of us.  Over seventeen years, the cost of insurance premiums has risen at 6 times the rate of inflation.  Over ten years, deductibles rose at 16 times the rate of inflation. Someone called this "strip mining the middle class." The NYT says,
"The reaction to opening a medical bill these days is often shock and confusion — for the insured and the uninsured. Prices and deductibles keep rising, policies are drowning in fine print, and doctors are jumping on and off networks...  With incomes for most Americans stagnant, individuals and families insured under the Affordable Care Act or through employers are bearing more of the cost of medical treatment..."

Workers’ contribution
to premiums

Thursday, September 29, 2016

CDC urges Americans to get a flu shot as soon as possible/ NPR

NPR tells us influenza vaccine comes in twelve flavors this year.  You can pick 3 antigens or 4.  With or without a squalene adjuvant? (Fluad is the first US vaccine to use the MF59 squalene adjuvant, though its manufacturer worked to get it into the US market for almost 2 decades.)  High dose or regular strength? Made in armyworm cellsdog kidney cells, or just the usual egg-based vaccine?

Sorry--the nasal spray flu vaccine (FluMist by AstraZeneca) is not recommended this year, since it didn't work the last three years.

CDC is concerned that fewer elders got flu shots last year.  Maybe that is because they, or their doctors, finally learned that there is no reliable evidence flu shots work in those over 65. Also see this.  (They do work to a degree in younger adults and older children.)

I averaged the efficacy results for the last 12 years, from CDC's website and an MMWR report for the 2008-9 seasonal flu vaccine, since CDC had omitted that (negative efficacy) year from its list. Using CDC's own data, the average efficacy of flu shots (how well they work in controlled clinical trials, which may be better than their real life efficacy) was a whopping 37%.

So if 5% of the population gets flu each year without being vaccinated, only 3 or 4% will get the flu when everyone is vaccinated.

As the Cochrane Collaboration noted in a 2014 review of this subject (one of many they have done) you would need to vaccinate 71 people to prevent one case of flu.

Got it?  Now go get your shot.

P.S.  There are 80 million American children.  Last year, there were 85 influenza-associated deaths in children, or one in a million.  We have no idea how many children suffered serious side effects from influenza vaccines.  We have no idea how many suffered side effects from FluMist, which gave them no protection.  Fifteen million doses of Flumist were delivered to the US market last year, at a cost of about $23 each, or $350 million total.  Nice work if you can get it.

Tuesday, September 27, 2016

Five Recent Medical News Stories That Invite Cynicism/ John Mandrola, MD

From Dr. Mandrola at Medscape, a compilation of recent events in medical "science" that make one wonder whether the practice of medicine is going to last much longer, given the amount of corruption now woven into it:  
Cynic: A person who believes that people are motivated purely by self-interest rather than acting for honorable or unselfish reasons
I don't want to be this person. Cynicism is ugly.
But when it comes to the making and translating of medical evidence, five recent events are ugly.
Event Number 1. The Journal of the American College of Cardiology (JACC)recently retracted a paper[1] published earlier this year. This is notable because JACC is cardiology's biggest journal and because retraction is the highest form of scientific punishment.
The retracted paper reported the results of the OASIS trial—a test of whether ablation of atrial fibrillation (AF) using the controversial Topera Physiologic Rotor Mapping Solution was better than conventional techniques.
The OASIS trial results dealt a crushing rebuke for rotor ablation. The proprietary mapping system failed to deliver. The authors of OASIS, led by Dr Andrea Natale, are widely published and influential in the field. Their paper was presented as a late-breaking session of this year's Heart Rhythm Society meeting.
JACC retracted the paper because of irregularities in the randomization process (basically, the editors said OASIS was presented as a randomized trial, but it wasn't) and because patients were recruited before the trial was registered.
Dr Natale countered publicly, saying that industry influenced the decision to retract the paper. In an email toheartwire from Medscape journalist Patrice Wendling, discussing the decision by JACC's editors, Dr Natale said the information contained in letters to JACC were known only to the investigators and industry; "thus, it [was] obvious that these individuals were acting on behalf and in the best interest of the company."
I wrote a column outlining three possible explanations for this event, all of which, in my opinion, are depressing: a seriously flawed trial made it through the editorial and peer-review process of a major journal, or an influential research group were guilty of scientific misconduct, or industry influenced an editorial decision of a scientific journal.
Event Number 2. Another cynicism-inducing paper[2] out this month detailed the finding that the "sugar industry paid for and was closely involved in development of an influential literature review,"[3,4] published by the New England Journal of Medicine in 1967. This review downplayed dietary sugar's links to coronary heart disease while pointing the finger at fat and cholesterol intake."
Authors from University of California, San Francisco analyzed internal documents from the Sugar Research Foundation, the precursor to the Sugar Association, to probe the history of how dietary guidelines were developed. They looked at more than 1500 pages of documents from a range of publicly available sources, including damning correspondence between sugar-industry representatives and Harvard researchers.
Speaking to heartwire , Dr Cristin E Kearns, the lead author of the report, said that if the evidence had been fairly presented, the recommendations would have been to reduce both fat and sugar, not just saturated fat.
Think of the people that may have been harmed by substitution of sugar for fat.
My friends—this is a big story. Think of the people that may have been harmed by substitution of sugar for fat. Look around at the populace of Western countries.George Santayana's famous, often misquoted, quote fits: "Those who cannot remember the past are condemned to repeat it."[5]
Event Number 3. The third article[6] that gets me down deals with the problem of medical overuse.
In a structured review of English-language articles on PubMed published in 2015, Daniel Morgan and colleagues identified 821 articles which addressed medical overuse. Their paper, published in JAMA Internal Medicine and available in full text online, identified the 10 most influential of these papers, detailing important types of overuse.
I see overuse too often; it's harmful to patients because it exposes them to more harm than benefit, and it is harmful to society because it wastes resources. At the core of the overuse detailed in this review was poor translation of evidence into practice. Does overuse persist because people are motivated out of self-interest?
Event Number 4. Recent decisions at the US Food and Drug Administration (FDA) suggest the bar for approval of new devices and drugs is too low.
Last year, the FDA approved the Watchman (Boston Scientific) left atrial appendage closure device, which is a plug placed in the left atrial appendage to prevent stroke. Only it doesn't.
In a clinical trial called PREVAIL, the device was tested against warfarin—the standard of care. The trialists set the lowest possible bar for the device; all it had to do was prove noninferiority. It failed. In counting up events, the device proved inferior to warfarin.
That an agency charged with judging clinical science considers the opinion of Hollywood actors demeans the process.
How did Watchman get approved, then? Advocates for the device used multiple tactics. They combined previous trial data, they "meta-analyzed" multiple studies; they criticized the PREVAIL trial for providing management of warfarin patients that was too good; and they harnessed the power of patient advocacy. The well-known actor Wilford Brimley spoke at the FDA session on behalf of the device. That an agency charged with judging clinical science considers the opinion of Hollywood actors demeans the process.
Event Number 5. And finally, a far worse crisis at FDA came to light on September 19, 2016, when the agency gave accelerated approval to eteplirsen (Exondys 51, Sarepta Therapeutics), the first drug for a rare form of Duchenne muscular dystrophy, specifically patients with a confirmed mutation of the dystrophin gene amenable to exon 51 skipping.
During the first pass at the FDA, an advisory committee evaluated the data and rejected it by a 7 to 3 margin with three abstentions. The scientific advisors rejected the drug because the trial included only 12 boys and had deeply flawed methodology.
Despite the negative vote, patient-advocacy groups and others pressured the FDA into a second hearing. And now, the agency has gone against its advisors and granted approval. A clinical benefit of eteplirsen, including improved motor function, has not yet been established, and in its approval, the FDA did require that the manufacturer complete a clinical trial to confirm the drug's benefit. The company estimates the cost of the unproven drug will be $300,000 annually.[7]
Compassion for patients with rare diseases does not mean we can or should suspend scientific principles.
Compassion for patients with rare diseases does not mean we can or should suspend scientific principles. Luciana Borio, MD, the acting chief scientist at the Agency Scientific Dispute Process Review Board, the board that resolves internal disputes at the FDA, wrote that she "does not believe the available data and information support accelerated approval of" the drug."[8]
Ellis Unger, MD, the director of FDA's Office of Drug Evaluation within the Center for Drug Evaluation and Research and the chair of the advisory committee, in an appeal of this eteplirsen decision, exuded both empathy and common sense: "Many of us would wish to approve this drug if we could. DMD is a horrible disease and there are no approved treatments. FDA takes seriously the patient perspective and our mandate to be flexible."[8]
But in this case, Unger explains, "FDA is charged with the responsibility of ensuring that drugs are shown to be effective prior to marketing, based on substantial evidence. If we were to approve eteplirsen without substantial evidence of effectiveness, or on the basis of a surrogate end point with a trivial treatment effect, we would quickly find ourselves in the position of having to approve a myriad of ineffective treatments for groups of desperate patients—in essence, allowing marketing based on desperation, patient lobbying, and the desire and need of hope."[8]
The Sarepta story is terrible because it shows the darkest side of healthcare—one that I see too often: the hijacking of fear and hope in susceptible people in order to foster profits and self-interest of others.
Editor's note: The FDA has made a Summary Review of this decision, including documents from FDA's scientists, available in full online.]
Patients and doctors want to approach new developments in science and medical evidence with the belief that it is honest and born from the desire to foster the greater good. We want our default bias to be rooted in a place of benevolence.
Taken together, these five events give me great concern about the profession that is my life's work. I will continue to fight back cynical thoughts, but it's getting harder.

Tuesday, September 20, 2016

We don't know if it works or is safe--but don't let that stop you, Doctor. Push Gardasil

WebMD Professional
Developed under the direction and sponsorship of Merck.
Helpful information when talking to parents about HPV vaccination

Prescribing Information     Patient Information
When talking to parents about the HPV vaccine…
Focus clearly on cancer prevention
The CDC suggests:
Consider telling parents that HPV vaccination is about cancer prevention: cervical, vaginal, vulvar, and anal1
"HPV can cause certain cancers, and the vaccine helps prevent HPV-related cancers and diseases caused by 9 types. I want to help protect your child from these cancers."
CDC=Centers for Disease Control and Prevention.
GARDASIL 9 is a vaccine indicated in females 9 through 26 years of age for the prevention of cervical, vulvar, vaginal, and anal cancers caused by human papillomavirus (HPV) Types 16, 18, 31, 33, 45, 52, and 58; precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV Types 6 and 11.

GARDASIL 9 is indicated in males 9 through 26 years of age for the prevention of anal cancer caused by HPV Types 16, 18, 31, 33, 45, 52, and 58; precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV Types 6 and 11.
(Indication continued below)

Select Safety Information
GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant) is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL 9 or GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant].
(Select Safety Information continued below)
Learn more about how to clearly recommend
HPV vaccination in your office ▶