Medical science is not a he-said, she-said process.  It is an incremental process of proving and disproving hypothesis based on biological evidence established through experimentation.   When facts don’t fit a theory or an assertion, it’s the latter that is wrong.

By giving two pseudo-scientists, Margaret Dunkel and Mark Geier, access to it’s press, the Sun has legitimized misleading and dangerous claims about vaccine safety and about the role vaccines play in causing all sorts of childhood disorders, particularly autism.  It perpetuates assertions that contribute to the rise of vaccine preventable diseases such as measles, whooping cough and cervical cancer.  And it has legitimized the idea that wild claims about a product causing autism are “science” even if such claims have never been proven scientifically or have been disproven.   To the Sun, just raising the possibility of danger is enough to merit publication.

I will not restate the scientific evidence about the significant benefits and incredibly small risks associated with vaccines.  One can read Stephen Salzberg’s editorial in Forbes for a concise discussion.

http://blogs.forbes.com/stevensalzberg/2011/07/17/the-baltimore-sun-sinks-deep-into-anti-vaccination-quicksand/

The problem is not with the Geiers and Dunkels of the world who peddle their conspiracy theories and lethal prescriptions for assuring vaccine safety.   The problem is with newspapers, new shows and politicians who promote fearmongering.

Would the Sun allow those ‘scholars’ who deny the Holocaust or claim astronauts never landed on the moon access to its editorial page?  Both types of conspiracy driven twaddle exist in spite of the facts, not because of them.  Yet the Sun, in giving Geier and Dunkel a platform, has given the scientific equivalent of Holocaust denialism legitimacy and renewed strength.

In so doing, it has shamed itself and empowered quacks to endanger the lives of children.

How did David Geier – who along with his father Mark Geier – conducted fraudulent research on how vaccines caused autism and enriched themselves by selling an autism “cure”, get appointed to the state of Maryland’s autism commission?

David Geier and Mark Geier are the state of Maryland’s answer to Andrew Wakefield. Like Wakefield, the Geiers have had their credentials as scientists shredded and have had paper retracted because of their bogus claims that vaccines and mercury preservative cause autism. Like Wakefield, the Geiers have made a bundle peddling snake oil diagnostics and dangerous treatments to kids with autism. In the Geier’s case it was injecting autistic children with Lupron, a drug used to perform chemical castration on sex offenders and reduce hormone levels to treat prostate cancer.

In my book Tabloid Medicine I noted that the Geiers deliberately manipulated data about vaccine safety to show a link between more shots and more autism and then went on to sell themselves as expert witnesses in vaccine liability cases and as the inventors of a new battery of tests and treatments for diagnosing and treating autism. I build on the work of others, including Kathleen Seidel who, as Seth Mnookin notes, “put together a blockbuster 16-part series on her website, neurodiversity.com. Similarly, in 2009, the Chicago Tribune ran a series that shone attention on the Geiers’ work, including “Miracle drug called junk science“ by Trine Tsouderos, “Autism treatments: Risky alternative therapies have little basis in science,” by Tsouderos and Patricia Callahan.

The Geiers sordid history was already in plain sight before Wakefield was finally exposed as a fraud as well as a fear monger by Brian Deer in his three part investigative series Secrets of the MMR scare.

So when David Geier submitted his application to be named to the Maryland Commission on Autism how was it that no one raised a question or objected until Mark Geier’s medical license was suspended the state’s Board of Physicians?

Or more to the point: How did David Geier get the nod in the first place? As a “diagnostician” no less?

As the Baltimore Sun’s Meredith Cohn dryly observed: “It’s not clear what specific element of his application won the seat on the panel, on which 60 people requested positions. Neither he nor his father has made political contributions, according to state data. And court records show that at one time, the family business owed more than $500 in back taxes to the state, which it was ordered to pay.”

http://www.baltimoresun.com/health/bs-hs-doctor-suspension-20110505,0,7283787.story

Here’s a clue: The Geiers did have their association with John L. Young, MD.

Who is Dr. Young and why might he be connected to David Geier’s appointment?

In 2009, Dr. Young “was the President of the Montgomery County Medical Society, the largest component medical society in Maryland. From 2007 to 2009, he was asked by Maryland Governor Martin O’Malley to serve as a Commissioner for the Maryland Community Health Resources Commission, and in 2009, was appointed by Governor O’Malley to serve on the Board of Regents for the University System of Maryland.”

That information is taken from the website of ASD Centers, which the Geiers set up to peddle Lupron and other dangerous and disproven autism treatments. That’s because John L. Young, MD — founded in 2008 — along with Mark Geier — ASD Centers.

http://www.autismtreatmentclinics.com/Staff.html

And there’s more: The Geiers set up an Institutional Review Board (IRBs are established to review the impact of clinical research on human subjects) to approve their own research, conducted by ASD Centers of course. The IRB called the Institute for Chronic Illnesses turned out to be Mark Geier’s home.

More problematic, John Young was a ‘co-investigator’ with Mark and David Geier in their Lupron research.

Even worse, Young was also a member of the IRB.

http://www.neurodiversity.com/weblog/article/98/

There’s more: “Dr. Young is Dr. Geier’s business partner in Genetic Consultants of Maryland and Genetic Consultants of Virginia; he, Dr. Geier and various business entities were codefendants in a 1994 medical malpractice lawsuit. He is also a newly-minted DAN! practitioner. According to his ARI listing, Dr. Young completed an eight hour training at the May 24-28 2006 DAN! conference in Washington, DC. Treatments he offers include antifungal pharmaceuticals and nutriceuticals, chelation, antiviral medications, and Lupron injections.)”

If I were the media, the state’s Board of Physicians or Governor O’Malley I might want to have a conversation with Dr. Young. I would ask him if he was involved with appointing David Geier. It might be interesting to find out what role he might have had in not bringing to light the Geiers’ past abuses to the Governor and the Board of Physicians.

South Florida Sun-Sentinel.com

Put Avastin, and the FDA, back on the fast track

Nicole Brochu

Sun Sentinel Columnist

April 7, 2011

Copyright © 2011, South Florida Sun-Sentinel

On food dyes and ADHD there was no reason to revisit an issue that channels the same approach to causality the Andrew Wakefield, Jenny McCarthy and anti-vax crazies used. (And shame on the media for not referring to the European Food Safety Agency report trashing the Lancet article most reporters cited – in tandem with a real life story of a kid being cured of ADHD by going natural. As in: “In 2009, EFSA re-evaluated the safety of the six color additives used in the Southampton study and concluded that the available scientific evidence does not substantiate a link between the color additives and behavioral effects.” )

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/FoodAdvisoryCommittee/UCM248549.pdf

Are reporters that biased or lazy that they can’t get beyond the he-said/she- said approach to reporting.

In any event, why, with this knowledge in hand did the FDA grant Center for Science in the Public Interest’s ( the same group that sued McDonald’s for offering Happy Meals to kids) citizen petition which was submitted in 2008?

Now the FDA has decided to allow pharmacists to compound a drug (Makema) developed by KV Pharmaceutical that significantly reduced the risk of certain preterm births in women who have had at least 1 prior preterm birth. Previously, the agent had only been available from pharmacies that had compounded the drug.” The FDA and ob-gyns had wanted a version of the injectable product that meet specific safety and efficacy standards. Since “Makena is a sterile injectable with a risk of contamination, greater assurance of safety is provided by an approved product. “

http://www.modernmedicine.com/modernmedicine/Clinical+News/FDA-wont-take-action-against-pharmacies-that-compo/ArticleStandard/Article/detail/714333?contextCategoryId=40157

After developing an FDA approved version of a drug that was in danger of becoming obsolete, KV promptly – and without warning – decided to charge $1500 for each dose. The company was rightly criticized for the sudden jump in price and did the right thing by cutting the retail price of the drug to $680 and offering the drug for free for a Medicaid price to a wide range of organizations.

The FDA decided to allow pharmacists to continue compounding even though KV developed the drug to put an end to the risk associated with compounding products. In case anyone didn’t know, the FDA is currently

Investigating “bacteria that sickened 19 people at Alabama hospitals and may have killed nine and has turned up at compounding pharmacy in Alabama.”

And then there were the pre-filled syringes of heparin and contaminiated compounded CF drugs.

There are many more such examples.

To be sure the FDA does have the authority to ensure the availability of products and indirectly considers affordability. It did so when it kept generic asthma inhalers on the market for several years rather than forcing them off to comply with an EPA requirement to remove inhalers powered by CFCs.

But that was a well-considered and organized action. This is a reaction to the media hype. Indeed, the FDA even got involved in a little demagoguery when it cited the fact that the NIH had provided KV with support to conduct clinical trials as the reason to allow the compounding they sought to eliminate. Give that logic, maybe every drug developed in cooperation with the NIH or based on NIH research should be compounded. How about a nice home made batch of Herceptin or HIV drugs such as Prestiva and Norvir?

All of this is preceded by the FDA’s children’s cough medicine obsession, you know that deadly drug that is linked to 39 deaths over 20 years, most of them do to overdosing by parents?

The FDA is in a shambles because of it’s pursuit of a politically correct position instead of a science-based regulatory policy. It’s already discourage the makers of cancer drugs from pursuing follow studies by shifting the Avastin endpoint to overall survival. Now, its piling on KV and permiting the type of compounding that KV’s drug was supposed to eliminate in an effort to protect expectant mothers. This is the Precautionary Principle run amok.

Formaldehyde, a poison and a common molecule throughout the universe, is likely the source of the solar system’s organic carbon solids—abundant in both comets and asteroids. Scientists have long speculated about the how organic, or carbon-containing, material became a part of the solar system’s fabric. New research from Carnegie’s George Cody, along with Conel Alexander and Larry Nittler, shows that these complex organic solids were likely made from formaldehyde in the primitive solar system. Their work is published online April 4 by the Proceedings of the National Academy of Sciences.

“We may owe our existence on this planet to interstellar formaldehyde,” Cody said. “And what’s ironic about it is that formaldehyde is poisonous to life on Earth.”

The major point of discussion was: Why did the media fail so miserably in covering the vaccine-autism link and why was it willing to give junk and pseudo science a platform?

No one answer was provided.   However it is clear that the motivations and approach of journalists that perpetuated this false narrative is alive and well.   The participants made the following points:

1.              Health care journalists limit their focus on conflicts to specific industries and give those ‘experts’ who raise questions about the integrity of companies, who claim links between chemicals and disease and who identify the profit motive as inherently evil are free pass.   Here are one recent example: FDA Probes Link Between Food Dyes, Kids’ Behavior‎ -

2.              Health care journalists ignore all ‘conflicts of interest’ except when it comes to medical product companies.  For instance, a story in Reuters claiming if doctors prescribed more generic drugs there would be more compliance and less spent on medications.  It was based on a study conducted by CVS and Harvard professors who claimed no financial interest.  The authors are: an executive of CVSCaremark, a doctor running CVS Caremark Harvardhttp://www.healthjournalism.org/blog/ leaves out her long affiliation with the left-leaning New America Foundation. Partnership for Improving Medication Adherence and another making money doing academic detailing.  The authors did not disclose this association or were not required to.   Even health care journalists are guilty of this deliberate oversight:  Joanne Kenen’s bio on

3.              Health care journalists continue to ignore the body of science in covering a study.  The Reuters article is a case in point:  The totality of evidence regarding the impact of generic drugs in improving adherence is unclear at best because most studies do not measure the impact of switching to a generic on compliance.  Such studies, with rare exception, fail to look at total treatment costs in specific therapeutic areas.  Finally, there is a body of evidence demonstrating that “allowing people to use only generic drugs would increase total treatment costs, not reduce them, and would lead to worse outcomes.”

http://tinyurl.com/4fahj3o

Similarly, coverage of the food color-ADHD ‘connection’ has ignored several large studies and a European Food Safety Agency review harshly criticizing the small ‘studies’ for the same reasons Wakefield’s MMR-autism ‘research’ was trashed.  http://www.efsa.europa.eu/en/press/news/ans080314.htm

The following blog post shows how an unbiased journalist would critically cover this story:

http://themoderatevoice.com/104925/todays-food-fear-mongering-in-the-wapost-food-dyes-and-hyperactivity-in-children/

All of which leads me to conclude that health care journalists need to be more vigilant in correcting those in the field.   There is nothing wrong and indeed much to admire in reporting or coverage with a strong point of view or bias.   I don’t think journalists should be penalized for having a particular bent or expressing opinions on most subjects.  At the same time it is wrong to apply a double standard on conflicts, (which will be the subject of another post)  fail to do a 5 minute search of well-designed studies that have clear endpoints or subject a medical or scientific claims about risks to the scrutiny of clear, replicable evidence.   Finally, journalists and headline writers have to stop framing possible associations as causation.

Obamacare’s Sales Force

By Robert M. Goldberg on 2.15.11 @ 6:08AM

House Republicans plan to cut $360 million in Obamacare funding in this year’s budget. That’s a good start, enough to slow implementation of the health care law but not stop it. But not good enough to stop the administration from spending $100 million to run an ad campaign and hire a sales team to push Obamacare to thousands of doctors. That’s right. Obamacare will use a sales force (with cars and expense accounts) to convince doctors that government health guidelines are the way to go.

The home of this marketing machine is Agency for Healthcare Research and Quality (AHRQ). Its budget of nearly $1 billion a year (starting in 2014 it will be more) is scheduled to be cut by only $25 million this fiscal year. Perhaps Republicans don’t know that AHRQ is the operating system for Obamacare as well as its campaign manager.

AHRQ is mentioned in the Obamacare law 12 times. The agency and its consultants — most of them true Obamacare believers — are responsible for determining what preventive services we get, what health care “quality” is, what should be cut from Medicare and what new technologies should be paid for.

AHRQ was behind the decision to restrict breast exams to women over 50. It supplied the “evidence” for annual end of life counseling for the same seniors it decided shouldn’t get screened for depression or hip fractures. Meanwhile, it’s funding radical organizations pushing for sex change operations and the autism-vaccine link.

And it has big plans for the rest of that money. The Obama administration is not content to control what doctors do. It wants to control what they know as well. Carolyn Clancy, AHRQ’s director, talks about “embedding” directives, guidelines, and reminders into the electronic health records of every American. AHRQ is spending millions to insert clinical decision support tools for a variety of purposes. One of the most prominently mentioned: end of life care counseling.

But AHRQ is not just content to “embed” Obamacontent into the lives of every American. It is also spending $50 million to “build a marketing campaign around comparative effectiveness research. (CER).” CER is promoted as information about what are the most medically and cost-effective treatments, drugs, and medical devices. But what works and what doesn’t can change almost daily and varies by individual. Simple blood tests and iPad-equipped sensors will be able to monitor many illnesses before they spread as well as individualize treatment of a disease.

AHRQ is not only spending hundreds of millions of dollars on studies claiming there’s insufficient evidence to either use or pay for such technologies.

AHRQ is spending millions to insure that its information is found more quickly and more often on the Internet. Over 70 percent of all Americans use the Web to seek out medical information. AHRQ plans to crowd out other sources of advice by making sure Obamacontent is embedded in as many websites as possible and using search engine tools to drive doctors and patients to government friendly or supported sites.

AHRQ is spending $34 million for an ad campaign to get doctors to adopt comparative effectiveness research. Here too, the campaign is heavy on Web-based tools with the goal of trying to get AHRQ and its consultants positioned as “experts” on Twitter, Facebook, YouTube, and search engines. It is buying up ad space in medical journals, which AHRQ is also flooding with its studies claiming most new technologies are more effective than old ones.

In case doctors don’t get the message “embedded” in health records and the Internet, AHRQ is hiring hundreds of Obamacare sales reps to convince physicians that Obamacare medicine is the way to go. AHRQ’s Obamareps will be paid $20 million to sell doctors AHRQ prescriptions. For instance, AHRQ reps will tell doctors that that all diabetes, hypertension, and prostate cancer treatments are more or less the same, often using data a decade old.

Medical science is way ahead of AHRQ. Doctors are able to tailor treatments to the race, gender, age, family history of a patient, as well as the pathways many forms of cancer takes. Today new imaging technologies and genetic tests can help predict cancer risk. But AHRQ’s sales reps will tell doctors there’s no evidence they save lives.

Obamacare ‘s overlords want to monopolize medical decisions and medical information while marginalizing everything else. That goal is central to setting up the health exchanges and limiting choice. AHRQ’s multi-million marketing campaign is critical to both. Unless Congress cuts it budget to nearly nothing, it will be impossible to repeal the law and replace it with something better.

Ms. Heffernan is right to be wary about many online health sites.  But her concern with WebMD is misplaced.  WebMD’s medical reporting copies other news outlets.  She should have focused on her own industry’s mangling of medical information.

http://tinyurl.com/4welcmv

I have a cold! Or do I? Can I Google it?

Child Flu Vaccine Seizures?

Posted by Sharyl Attkisson

More confusing news for parents trying to do the best, safest things for their children when it comes to vaccination.

According to a Vaccine Safety “update” issued by the FDA on Jan. 20, there’s been an increase in reports of febrile seizures among infants and children following this year’s flu vaccine. Febrile seizures are seizures associated with fever.

According to the FDA:

“FDA and CDC have recently detected an increase in the number of reports to VAERS of febrile seizures following vaccination with Fluzone (trivalent inactivated influenza vaccine or TIV, manufactured by Sanofi Pasteur, Inc.). Fluzone is the only influenza vaccine recommended for use for the 2010-2011 flu season in infants and children 6-23 months of age. These reported febrile seizures have primarily been seen in children younger than 2 years of age.”

The FDA says 42 more seizures than usual were reported through Dec. 13; most within a day of the child receiving the flu vaccine. The FDA recommends parents take no action based on this information. They should, the FDA says, continue getting their children vaccinated against flu, as usual. (It should be noted that non-government medical experts differ on the issue of whether flu shots should be given to children.)

The FDA points out that data from VAERS, the Vaccine Adverse Event Reporting System, is preliminary and serves as a sign that further investigation is warranted. The maker of the flu vaccine in question, Sanofi Pasteur, has issued a statement saying that no clear link has been established between the flu shot and the seizures, and the cases may be nothing more than coincidence.

And the CBS take is:

Even with “no clear link established,” the mere suggestion of a link may be troubling to parents.

Not content to stop there, CBS adds a link to another study that has nothing to do with flu shots:

http://www.cbsnews.com/htdocs/pdf/Molecula.pdf

The study is put there to connect the dots between the allegations in the CBS report and autism.  But the research merely points out that in animals early life seizures can result in cellular and molecular changes that could contribute to learning and behavioral disabilities”

As  the LeftBrainRightBrain blog (points out):  “Attkisson has either not read the study she cites, does not understand it, or has a very dark agenda. The paper discusses patients with early life seizures and epilepsy. Attkisson gloms on to the findings and applies them, with no credible reason, to the general population.

The 42 extra cases of febrile seizure reported in the VAERS database do not come close to establishing causality. Instead of telling readers the FDA report is no cause for alarm, Attkisson does the exact opposite.

And Attkisson has been a stalwart in using CBS News to flack for and support anti-vaccine causes:

http://lizditz.typepad.com/i_speak_of_dreams/2008/07/sharyl-attkisso.html

Where are the health care journalists and watchdog types when it comes to CBS News as a platform for anti-vaccine rhetoric?  It’s time to demand that CBS both explain this troubling pattern and seek to ensure it’s coverage of vaccine safety issues – as well as other medical news – is science-based.

It should worry about the lives of kids more than it does the future of one of it’s sit-coms.