On and off the battlefield, uncontrolled bleeding and inflammation from traumatic brain injuries (TBI) is the leading cause of death among our soldiers as well as young adults.  Over the past decade, a drug to control hemophilia has be used to stop brain bleeding faster TBI caused bleeds more quickly had helped reduce death and post TBI disabilities.   And recently scientists began work on a simple blood test for diagnosing head trauma as well as a new drug that shuts down inflammation itself.

Current treatments might not have been available if something called comparative-effectiveness research (CER) was in place ten year ago. CER compares the cost and effectiveness of old technologies in treating a disease to medical innovations. Under Obamacare, CER is being used in determining whether new technologies can be covered by health plans, Medicare and the Veteran’s Administration.  A recent CER study stated that there was no evidence that a clotting drug used to save the lives of soldiers in Iraq and Afghanistan as well as our neighbor’s kids was cost-effective.  What impact will CER have on future TBI treatments as well as other innovations developed to battle cancer, Alzheimer’s and Parkinson’s?

CER proponents such as Donald Berwick, the administrator of the Center for Medicare and Medicaid Services, believe that most medical innovation increases healthcare spending without adding any benefit.  They believe CER can be used to select innovations that can reduce costs without harming patients and free up spending for other purposes.

But CER only looks at the comparative cost of everything from the government’s perspective and the average response to the average person, not the value of innovations to our families and friends. More troubling, CER does not measure the impact of requiring more time, money and clinical trials on the number of innovations or what effect fewer innovations would actually have on our lives.

We conducted such a study.  And we found that the added time, cost and regulation could reduce R&D investment by $32 billion over the next decade.  That would cost Americans $4 trillion in economic activity and snatch 81 million years of life from our families and friends. Our research confirms the analyses of other economists that an increase in R&D is associated with increases in wealth and longevity.  For example, University of Chicago Economists, Kevin Murphy and Robert Topel, estimated the social-economic value of a 10 percent reduction in the mortality associated with cardiovascular disease and cancer around $10 trillion.

CER advocates such as Dartmouth University physician Jonathan Skinner believe that government should pay for any technology that costs more than $50,000 a year. They make no bones about the fact that many innovations would be not paid for under this formula.  Skinner believes that “the antagonism toward comparative effectiveness research…suggests a bit of magical thinking — the notion that the country can avoid the difficult trade-offs that cost-utility analysis helps to illuminate…It represents another example of our country’s avoidance of unpleasant truths about our resource constraints.”^[1]

In fact, our analysis suggests that the real trade-off isn’t between the government spending money on cancer drugs or pap smears or high speed railways. 

Yale University Economist William Nordhaus estimates the value of innovations in medicine during the second half of the twentieth century are about equal to growth in Gross Domestic Product (“GDP”) over the same fifty-year period. In other words, Nordhaus estimates that we could have spent more on food, clothing, entertainment, education, vacations, airplanes etc. and less on medical innovation. But in doing so we would essentially have to accept 1950’s levels of care over the past 50 years. 

Our research estimates what spending less on medical progress as a result of CER as another hurdle to developing and using medical technologies.  Our study confirms what Nordhaus and others have concluded: “the social productivity of health-care spending might be many times that of other spending. If this is anywhere near the case, it would suggest that the image of a stupendously wasteful healthcare system is far off the mark.”  And it suggests that CER is not only misguided, it’s dangerous to our health and quality of life too. That’s the unpleasant truth CER advocates seeming willing to ignore

Mistakes are the portals of discovery.

James Joyce

Smart.

In further news, ODAC will vote on the fate of Avastin's breast cancer indication at the agency's hearing on the proposed withdrawal of the claim, marking the third time in four years that the panel has been formally polled on whether the VEGF inhibitor should be used in this population. It voted against approval the previous times.

The announcement that ODAC will have a voting role contrasts with CDER’s original expectation that committee members would be asked to provide advice and recommendations but not vote.

Karen Midthun explains that since this is an administrative hearing, procedures will differ from those of a typical advisory committee meeting and may bear more resemblance to a court case.

According to Karen, "It may help to think of this as, in some ways, like a trial." Representative and will lead the meeting. Panel members will have an opportunity to question witnesses appearing on behalf of Genentech and CDER.

"As with a typical advisory committee meeting, we will ultimately ask you to vote as a committee on the issues that are the subject of the hearing," the letter states. "There will not be an immediate decision by FDA at the hearing. Instead, as with an advisory committee meeting, FDA will consider the committee's input and will announce its own ultimate decision at a later date."

The Pink Sheet opines that, “The decision to give ODAC a voting role would seem to bode ill for Genentech in light of the panel's previous negative reviews of bevacizumab for MBC.”

But there’s a third option other than yea or nay. FDA is leaving an opening for Genentech to hold on to Avastin's metastatic breast cancer indication even if Commissioner Margaret Hamburg determines existing evidence has not demonstrated bevacizumab's efficacy or safety for this use.

Commissioner Hamburg can decide to retain bevacizumab's accelerated approval in first-line MBC while the company conducts additional studies to confirm clinical benefit even after determining that the grounds for withdrawing the claim have been met.

The Pink Sheet reports that Roche/Genentech is seeking a broad label in metastatic melanoma for the just-filed oral BRAF inhibitor vemurafenib (formerly PLX4032) and priority review, which could possibly enable a U.S. launch at the end of 2011.

It's geared as a treatment for the roughly half of metastatic melanoma patients who test positive for the BRAF V600 mutation. A companion diagnostic to test for the mutation has been developed by Roche Molecular Systems, and has also been submitted for approval.

As a personalized therapy for the tough-to-treat disease, the drug has been widely described as a game-changer in melanoma.

Drug companies should not let overeager sales representatives make do-it-yourself Web videos and post them online without review by compliance experts.

Duh.

Warner Chilcott received for a notice of violation letter for a sales-rep-created-and-produced YouTube video promoting its new osteoporosis drug Atelvia (risedronate delayed-release), which featured a female sales representative talking about the drug to an enthusiastic staff member in a physician's office.

The letter was generated by a "Bad Ad" program complaint, and FDA noted that the video was never submitted via a FDA Form 2253 as required.

Oops.

According to the May 5 NOV letter to Warner Chilcott, which was posted to the FDA Web site May 9, "The video was posted by the sales representative on the website YouTube.com under the direction of a Warner Chilcott district manager."

Please note that this does not mean that YouTube is out of bounds.  It's not the channel that's non-compliant, it's the content.

Sins of omission are seldom fun.

From the Forest from the trees department, The Wall Street Journal reports:

A federal trial judge on Tuesday acquitted a former GlaxoSmithKline PLC lawyer in a high-profile corporate misconduct case, dealing a blow to the government's effort to target individuals in probes of the pharmaceutical industry.

U.S. District Court Judge Roger Titus in Maryland took the rare move of acquitting former Glaxo lawyer Lauren Stevens without sending the case to the jury.

Judge Titus called his summary move to acquit Ms. Stevens a first in his seven-and-a-half years on the federal bench. "The defendant in this case should never have been prosecuted and she should be permitted to resume her career," he said.

Prosecutors had alleged Ms. Stevens obstructed a Food and Drug Administration investigation into whether Glaxo had improperly promoted the antidepressant Wellbutrin for weight loss, a use not approved by the FDA.

The government's defeat points to the difficulty of prosecuting individuals over alleged wrongdoing at large corporations, where teams of people may be involved in a matter and it is hard to show that executives intended to break the law.

Despite calls for prosecution of top Wall Street figures in the wake of the 2008 financial crisis, the Justice Department has brought only a handful of cases against individuals, and lost some prominent cases.

Ms. Stevens's sudden acquittal could hurt other government efforts, including the long-running investigation of Glaxo for marketing issues related to several drugs, said defense attorneys. They said the Justice Department and the Department of Health and Human Services may have to review their larger strategy of targeting executives and lawyers at pharmaceutical companies.

The Justice Department cannot appeal Tuesday's acquittal. "We believe these charges were well-founded and that the jury should have been allowed to deliberate and decide this case," a department spokesman said.

Pharmaceutical companies have paid billions of dollars to settle various marketing-related charges with the government, but only a few executives have pleaded guilty to any crimes.

Government officials have said they decided to go after more individuals to create a stronger deterrent and prevent companies from viewing fines as merely "a cost of doing business."

Prosecutors alleged Ms. Stevens falsely denied that the company had promoted Wellbutrin for unapproved or "off-label" uses, despite knowing that the company had sponsored programs with doctors' groups involving Wellbutrin. Companies are barred from off-label marketing but doctors can generally prescribe an FDA-approved drug for any condition.

Defense lawyers for Ms. Stevens said she provided legitimate and zealous representation of Glaxo and relied in good faith on the advice she received from an outside law firm.

The judge agreed, saying it would be a "miscarriage of justice" to let the case get to the jury.

"We did not have a bad five minutes in that courtroom; if it had been a prize fight, they would have stopped it," said Ms. Stevens's lawyer, Reid Weingarten, who has represented Cabinet secretaries and corporate chiefs.

It is rare for the government to charge a lawyer over advice given to a client, because such conversations are generally protected unless the lawyer is helping the client commit a crime.

Judge Titus's ruling is likely to make such prosecutions rarer still. "There is an enormous potential for abuse in allowing prosecution of an attorney for the giving of legal advice," the judge said.

The government has long been investigating Glaxo over various allegations related to sales of antidepressants Paxil and Wellbutrin, as well as its former popular diabetes drug Avandia. Glaxo hasn't been charged with wrongdoing in these cases, but the investigation is continuing, according to people familiar with the matter.

Its outside counsel, King & Spalding LLP, didn't return calls requesting comment.

The government hasn't said whether the prosecution of Ms. Stevens was part of an effort to push Glaxo into a plea deal. It said in court documents in December that the Stevens case was part of an "ongoing underlying health-care fraud investigation" looking at her and "potential criminal activity by others."

The company has declined to comment on the cases, and it hasn't said under what terms Ms. Stevens left the company last year.

It said Tuesday that it was "pleased" with her vindication.

"The acquittal certainly strengthens Glaxo's hand in negotiations with the government about a corporate resolution of their case," said John Fleder, a defense attorney with Hyman, Phelps & McNamara PC who wasn't involved in the case.

FDA officials and the inspector general of the Department of Health and Human Services have said that the government wants to make more use of an administrative option to punish executives by excluding pharmaceutical company leaders from the industry. That option may look more attractive after the failure of the criminal case against Ms. Stevens.

Companies that employ an "excluded" executive can be prevented from selling products to the U.S. government—which almost all pharmaceutical firms do. In essence, the step can force a company to dump its chief in order to do business with Medicare or the Veterans Administration.

In April, the HHS inspector general created a firestorm in the drug industry when the agency said it intends to exclude the longtime chief executive of Forest Laboratories Inc, Howard Solomon. The company has protested the move and said Mr. Solomon had nothing to do with marketing violations for which the company agreed to pay more than $300 million in civil and criminal fines.

Gary Schwitzer's HealthNewsReview Blog  (fully funded by the for profit HealthDialog, a point I raise only because Schwitzer makes a federal case about pharma funding of researchers) runs  healthnewsreview.org.   He has never found a new drug or treatment worth paying for.  Which raises the question of whether or not he would accept the state of medicine in 1980. 

I am shocked at how uninformed the rant against Provenge and other medical breakthroughs was.   In 1980 the average cost for treating colon cancer was $20K, about $42K in 2010.  In 1980 the average five year survival rate for colorectal cancer was 50 percent for people age 45 and over among patients whose cancer had spread to lymph nodes  Today the average cost of colon cancer therapy is $40K with a 5 year survival rate  at a similar stage is 70 percent.  The age-adjusted death rate was 17.6 per 100,000 men and women per year. These rates are based on patients who died in 2003-2007 in the US.  

Advances in interceding years provided, as you described Provenge (which has extended the life expectancy of end stage prostate cancer patients by 2 years) marginal benefit.  That’s on top of a decline in mortality rates from previous treatments and increase screening.

David Cutler noted that “age-adjusted cancer mortality increased by 8 percent between 1971 and 1990, twice the increase from 1950 through 1971. However, between 1990 and 2004, age-adjusted cancer mortality fell by 13 percent. This drop translates into an increase in life expectancy at birth of half a year--roughly a quarter of the two-year increase in life expectancy over this time period and a third of the increase in life expectancy at age 45.”   Similarly,  Murphy and Topel estimate that a 1 percent reduction in cancer mortality would be worth $500 billion.  Since the death rate from prostate cancer has decline by 37 percent since 1992, the worth of that reduction is $18 trillion.

So would you not have spent more money on increasingly more expensive drugs because at that point in time the benefits were marginal. 

That begs the question: would he forfeit the gains in health derived by increased screening and better drugs over the past 30 years to buy more of the kind of cancer care we had in 1980.  Or his just willing to forfeit gains going forward. 

The Obama Watch

Hard on Drug Execs, Soft on Dictators

By Robert M. Goldberg on 5.3.11 @ 6:07AM

I was in Israel for two weeks hearing nothing but how the Obama administration is tougher (in action and language) on Israel than it has been on the Muslim Brotherhood (the White House seder included a Tahrir Square   salad) and Syria's dictator Bashir al-Assad.

Now it turns out that Team O is tougher on drug company CEOs than it is on brutal dictators and a movement whose goal is wiping out Israel. The administration is applying a little used government approach to knee-capping executives it doesn't like by threatening that HHS won't allow Forest Laboratories to sell medications to Medicare, Medicaid, and other government health programs (which means every health plan under Obamacare) unless it tosses the company's CEO, Howard Solomon. According to news accounts, the action is being taken because government lawyers claim that just fining the company billions isn't stopping illegal behavior. But neither Mr. Solomon nor Forest has been found guilty of any wrongdoing. Here's the WSJ account:

The Health and Human Services department startled drug makers last year when the agency said it would start invoking a little-used administrative policy under the Social Security Act against pharmaceutical executives. This policy allows officials to bar corporate leaders from health-industry companies doing business with the government, if a drug company is guilty of criminal misconduct. The agency said a chief executive or other leader can be banned even if he or she had no knowledge of a company's criminal actions. Retaining a banned executive can trigger a company's exclusion from government business.

Can you imagine the administration using this tactic against health IT firms, unions, the New Black Panthers, ACORN, or investment banks?  For different reasons for each, the answer is "No."

Health IT firms are the favorite sons of HHS, the New Black Panthers, of municipal officials who milk pension funds and funnel money to their pet projects, unions are -- well enough said -- and investment banks would never be touched because that would trigger panic in the bond markets upon which the administration relies to finance the mounting debt. 

So picking on the CEO of a company that has already paid out $300 million in fines to avoid a government lawsuit regarding marketing practices makes political sense, even if Pharma supported Obamacare. My guess is that it will lead companies to be much less likely to make products available to government programs. Or maybe the administration will force sales at specific prices in exchange for a "promise" not to rough up CEOs. That is as close to government extortion as one can get. This, from an administration that promised to be more business friendly.

Meanwhile the threat against Forest and its CEO is more draconian than actions the Obama administration is taking against Assad. The dictator who has slaughtered his people, aided Iran, built a uranium-enrichment facility, staged the Hezbollah takeover of Lebanon, and whose country is soon to be part of the UN Human Rights Council has received a stern warning from the president but nothing more.

As for the administration's toothless response to Assad (well captured by the brilliant Barry Rubin), note how an administration official in quoted in the New York Times on these points:

Administration officials say that while they lack many effective economic tools, they believe Mr. Assad is sensitive to portrayals of his regime as brutal and backward. "He sees himself as a Westernized leader," one senior administration official said, "and we think he'll react if he believes he is being lumped in with brutal dictators."

Is this for real? How cannot one be sarcastic and hypercritical when leading U.S. officials think that a ruthless dictator -- in fact, the most cleverly ruthless dictator in the Arabic-speaking world -- really cares if people in the West say mean things about him."

The administration only picks on people and enterprises it can bully for show, without thinking through the consequences. Meanwhile it avoids taking on real evil or illegal activity when it suits the political goal of the moment and fits those naive narratives shaping the administration's actions. Forest and its CEO paid their debt in full. The effort to can Solomon is gangster government that serves a short-term political purpose while the administration's inaction towards Syria emboldens a chief executive of whom Rubin writes: 

It would be impossible to find someone more eager to be a brutal dictator and who does not see himself as a Westernized leader. If this were the "Godfather," Bashar would be Michael, not Fredo.

If the Obama Administration doesn't understand this, it understands nothing. Yes, that's the point. It understands nothing.

A new survey released yesterday by the Massachusetts Medical Society reveals that fewer than half of the state's primary care practices are accepting new patients, down from 70% in 2007, before former Governor Mitt Romney's health-care plan came online. The average wait time for a routine checkup with an internist is 48 days. It takes 43 days to secure an appointment with a gastroenterologist for chronic heartburn, up from 36 last year, and 41 days to see an OB/GYN, up from 34 last year.

As the Wall Street Journal opines, “Combined with insurance regulations that suppress innovation and competition, this reality helps explain why Massachusetts premiums are among the highest in the U.S. The current physician shortage was inevitable without new doctors.”

Massachusetts health regulators also estimate that emergency room visits jumped 9% between 2004 and 2008, in part due to the lack of routine access to providers. The Romney-Obama theory was that if everyone is insured by the government, costs would fall by squeezing out uncompensated care. Yet emergency medicine accounts for only 2% of all national health spending.

Another notable finding in the Medical Society survey is the provider flight from government health care. Merely 43% of internists and 56% of family physicians accept Commonwealth Care, the heavily subsidized middle-class insurance program. The same respective figures are 53% and 62% for price-controlled Medicaid. Government health insurance may be great, but not if it can't buy actual health care.

The Medical Society also finds "a continued deterioration of the practice environment for physicians in Massachusetts."

Mitt happens.

From the pfolks at PhRMA, some interesting state and national data on biopharmaceutical economic contribution to the US economy.

Here’s an interactive map presenting state economic impact data. The data reflect analyses conducted by Archstone Consulting.

To see select thumbnail information, click on an individual state. Subsequent landing pages provide more detailed information, with links to two-page Archstone fact sheets, which include state-specific data on employment, economic output and research and development activity, as well as Battelle fact sheets on states’ efforts to attract and develop a local biosciences presence.

The U.S. fact sheet with national economic impact data is available here.

Now that's a stimulus package.

According to a new survey, US doctors do not believe industry funding significantly biases their continuing medical education -- and they are unwilling to pay for “impartial sponsorship.”

Dr. Jeffrey Tabas, an emergency physician at the University of California, San Francisco, surveyed attendees at five CME courses delivered by the International AIDS Society-USA, which receives industry funding.

Less than half thought paying higher registration fees for CME activities would make sense and only 15 percent would like to see industry funding completely removed.

"Because they feel in general there is not a lot of bias, they are not willing to pay to reduce it," said Tabas.

Drugmakers seeking FDA approval for biosimilars will pay application fees similar to charges for brand-name medicines.

The Food and Drug Administration plans to break down the cost to review so-called biosimilars into separate payments with more money charged up front during development, according to a proposal released today. The fees will be assessed annually and followed by application charges, establishment and product fees required for all drugs.

 “Given that the approval pathway for biosimilar and interchangeable biological products is new, FDA services are most critical for continued and successful development of biosimilar and interchangeable biological products during the investigational stage prior to submission of a marketing application,” the agency said in its Federal Register notice.

The FDA’s proposal covers fiscal years 2013 to 2017, and comments will be accepted on the plan until June 9.

A state bill making its way through Sacramento would ban the practice of requiring patients to pay a percentage of drugs that fall into so-called specialty tiers. These drugs are necessary for millions of patients nationwide who suffer from cancer, multiple sclerosis, scleroderma, rheumatoid arthritis and other auto-immune diseases.

The bill, introduced by Assemblywoman Fiona Ma, D-San Francisco, would place a $150 out-of-pocket cap per month on medication for all patients. Co-insurance health plans, which require a patient to pay a percentage of the cost for treatment, would also be banned.

The health insurance industry opposes the measure, saying the overall cost of prescription drugs rose by nearly 7 percent last year alone, and these specialty drugs are extremely expensive. If patients don't pay more, nearly $220 million in losses would be passed on to other premium holders.

"The cost of a thing is the amount of what I call life which is required to be exchanged for it, immediately or in the long run."

-- Henry David Thoreau

Karen Midthun, FDA's presiding officer for the June 28-29 hearing, has indefinitely postponed the submission deadline for written summaries of the parties' arguments.

The summaries had been due on May 5. However, in a May 2 letter to counsel for Genentech and CDER, Midthun said the submissions will instead be due one week after the formal hearing notice is posted for public review in the Federal Register.

Midthun concedes that the formal notice "will be issued somewhat later than we had intended," but that delaying submission of the parties' written arguments "will give you a better opportunity to address the issues as framed in the notice."

When the notice will be published remains in question. "We do not, at this point, know the exact date on which the notice will be posted," Midthun tells the parties. "A copy will, however, be sent to you on that date."

And speaking of Avastin, a new 1200 patient NIH trial has confirmed that it’s “just as effective” as Lucentis. The related news is that a new model for Medicare payments (ACOs, scheduled to launch in January 2012) may offer another way to address the cost differential.

(Note: The study found no major differences in major adverse events between patients taking the two treatments. However, patients prescribed Avastin were slightly more likely to experience non-specific serious adverse events, primarily hospitalizations, than those given Lucentis (24.1% versus 19%. Add to that a Genentech-sponsored study, suggesting an 11% higher risk in mortality and 57% higher risk of hemorrhagic cerebrovascular accident in patients treated with Avastin versus Lucentis and “just as effective” is put in a better perspective.)

CMS released a proposed rule in late March laying out a framework for the first phase of an ACO program, which is being established under the Affordable Care Act.  (An ACO is an organization of health care providers that agrees to be accountable for the quality, cost, and overall care of Medicare beneficiaries in their care and in the traditional fee-for-service program.

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's 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. 

I’ve just returned from deep in the heart of America’s Medicine Chest (Princeton, NJ), where I was proud to chair the Social Media for Pharma conference.  The conversation included when FDA guidelines might be released (and if it even matters), the appropriate balance between sales and education, the role of the digitally empowered healthcare consumer, the clash between marketing and medical/legal review and, of course, who’s doing what – and how can it be measured?

A few selected comments from the esteemed faculty (attributed where appropriate, unnamed otherwise):

Wendy Blackburn (InTouch Solutions) – “True two-way dialogue between pharma companies and patients is like sex in high school.  It’s risky.  Everyone is talking about it.  Everyone thinks they want to do it.  No one is really sure if anyone is doing it or not.  It’s definitely happening.”

Pat Connelly (Millennium Pharmaceuticals) – “I have tried and failed with more social media ideas than anyone I know.” Good for you Pat.  Remember what Thomas Edison said when asked why he was so successful:  “Because I fail faster than anyone else.”

Tony Jewell (AstraZeneca) – “If I had known that our live tweet-up was an industry first, we probably wouldn’t have done it.”  (That got a laugh – but I don’t think it’s true.)

Mark Karch (Appature) – “Data is the new black.”  (That may be so – but does it make me look fat?)

Marc Monceau (J&J) on dealing with the “Motrin Mom’s” issue (which broke online after 5pm on a Friday) – “We had to be nimble and quick.”  (Which is a good idea if you want to avoid the heat of the candle stick.)

Joseph Kim (Shire Pharmaceuticals) -- "Inside pharma, social media musn't be a battle between cheerless eggheads and happy morons."

Ron Petrovich (Mayo Clinic) – “We do not offer tiger blood transfusions – yet.”

Anonymous -- “When it comes to social media, if you stick your head in the sand, you’re going to get kicked in the ass.”

Anonymous – “The rules of healthcare social media are like your dog’s invisible fence – you’re not sure where the perimeter is – but it’s shocking when you find out.

Anonymous – “Whenever somebody says they’re being transparent, I suspect they’re hiding something.”

And to quote myself – “Social media is communications at the speed of life. As Marshall McLuhan wrote, At electric speed, all forms are pushed to the limits of their potential.  (Replace “electric” with “digital” and it’s amazing how prescient McLuhan was.  That’s genius.) That’s a wonderful challenge, to be pushed to the limits of our potential.  If you are not ready to do so, it’s time to look for another job.

Onwards and Excelsior.

From the Pink Sheet:

Data Exclusivity Remains A Top Issue In USTR's 2011 Special 301 Report

The failure of U.S. trading partners to adequately protect pharmaceutical test data remains one of the top concerns of the United States Trade Representative in its 2011 Special 301 Report on intellectual property rights.

The report encourages several countries to protect against unfair commercial use and unauthorized disclosure of undisclosed test or other data generated to obtain marketing approval of pharmaceutical products. The countries cited include Algeria, Argentina, Chile, India, Indonesia, Pakistan, Brazil, Dominican Republic, Ecuador, Egypt, Malaysia, Mexico, Turkey and Paraguay.

In its annual Special 301 report, the USTR places U.S. trading partners deemed to provide insufficient IP rights protection, enforcement or market access on a Priority Watch List, Watch List or Section 306 monitoring list. Of 77 trading partners reviewed, the USTR put 12 countries on the Priority Watch List, 29 on the Watch List, and one, Paraguay, on the monitoring list. China, India, Israel, Thailand and Venezuela are among those on the Priority Watch List.

The report, released on May 2, includes an extensive discussion of China. It notes that pharmaceutical manufacturers have reported positive results from China's "Program for Special Campaign on Combating IPR Infringement and Manufacture and Sales of Counterfeiting and Shoddy Commodities," which was launched in October 2010.

"According to rights holders in this sector, law enforcement has been reaching out to individual companies, investigating leads early on, and bringing criminal prosecutions against infringers," the report states. "Rights holders detect more diligence and promptness on the part of Chinese authorities in developing criminal counterfeit pharmaceutical cases."

However, the report says the United States is troubled by China's May 2010 prosecution guidelines that tripled the threshold for investigating and prosecuting trade in counterfeit goods.

Christopher Singer, Pharmaceutical Research and Manufacturers of America President, International, said in a statement on the report that China "continues to circumvent data protection obligations and permit widespread distribution of unregistered active pharmaceutical ingredients."

Singer also said India has had significant delays in providing data protection and expressed concern about the scope of patents and coverage of incremental innovation, delays in providing patents and recent court actions to limit or undermine patentablility. He also expressed support for USTR's out-of-cycle review of Thailand, saying the country's "weak protection" of IP rights is especially troubling.

While Japan, Poland and New Zealand did not make either watch list, the USTR singled them out in the report, citing the pharmaceutical industry's concerns about their policies.

U.S. industry has "expressed serious concerns about the policies and operation of New Zealand's Pharmaceutical Management Agency," including the transparency, fairness and predictability of its pricing and reimbursement regime, the report states.

The report says industry also is concerned about health care reform legislation introduced in Poland in 2010 that would alter the country's pricing, reimbursement and clinical trials policies. The report also notes that the pharmaceutical industry is upset that it has not been able to meet with Poland's Ministry of Health to discuss these initiatives.

As for Japan, USTR says it is seeking further improvements in transparency and reform of reimbursement and regulatory systems that "would facilitate the timely introduction of innovative pharmaceuticals and medical devices into Japan's market."

The 2011 report is similar to last year's. In addition to data exclusivity, the USTR also reiterates its concerns about patent laws in India and the Philippines that prohibit patents on certain chemical forms unless they show increased efficacy.

Despite making major concessions to the United States, Israel remains on the Priority Watch List. Last year, it reached an understanding with the U.S. to strengthen laws on protection of pharmaceutical test data and patent term extension and to publish patent applications 18 months after the application is filed. While Israel has submitted legislation for the protection of pharmaceutical test data, the report says it has not submitted legislation regarding patent term extension or patent publication.

Compulsory licensing, once a major issue for USTR, is mentioned only with respect to China and Ecuador. China's draft regulations for patenting technologies used in national standards may allow a compulsory license if a patent holder does not grant a royalty-free license. As for Ecuador, the report says simply that the U.S. "will continue to monitor developments concerning compulsory licensing of pharmaceutical and agricultural chemical products."

Jamie Love, director of Knowledge Ecology International, an organization that closely tracks IP and trade policy, said the report does not convey the arm twisting that goes on behind the scenes.

"The USTR discussion of IPR policy concerns seems muted in the report, compared to the pressure that the U.S. government actually applies both behind the scenes and in different trade fora," Love said in a blog posting. "In practice, the 301 Report represents only a fraction of the issues being raised and the pressures being applied by the White House and various federal agencies."

Industry also is concerned about the inclusions of IP rights in a regional trade agreement currently in development, the Trans-Pacific Partnership (TPP) Agreement. The United States and its TPP partners - Australia, Brunei Darussalam, Chile, Malaysia, New Zealand, Peru, Singapore and Vietnam - held their sixth round of negotiations in Singapore last month and are to hold the seventh round the week of June 20 in Vietnam. The U.S. expects the agreement to increase American exports to the Asia-Pacific.

PhRMA is advocating for a strong IP chapter. In an April 2011 document, "PhRMA Views: Intellectual Property (IP) Chapter for the Trans-Pacific Partnership (TPP) Agreement," the association said data protection is essential to recoup R&D expenses. It cites the provision in the U.S. health care reform law that provides 12 years of data exclusivity - the time during which a generic or other competitor cannot use clinical data generated by an innovator to obtain marketing approval - for biologics.

PhRMA also says countries should be required to provide patent term adjustments to compensate for the loss of effective patent term from delays in marketing approval and the issuance of a patent. And it says the TPP "must include a mechanism to permit a patent owner to resolve patent infringement issues prior to marketing approval of the infringing pharmaceutical product."

From the pages of the New York Times:

Doctors' Prescription Records

To the Editor:

A recent Business Day article reported that the Supreme Court will review a Vermont law that limits the sale of doctors’ prescription records (“A Fight Over How Drugs Are Pitched,” April 25). The high court should invalidate the law. Not only is it redundant, it also undermines federal efforts to promote drug safety.

The American Medical Association already runs a national program that allows doctors to opt out of having their data available for sale. There is no need for states to duplicate its efforts.

Further, pharmaceutical companies rely on physicians’ prescription records to disseminate F.D.A.-directed safety warnings. Without access to doctors’ prescription data, they don’t know how many patients are taking specific drugs, or for how long. Such data are crucial to addressing safety issues quickly.

PETER PITTS
New York, April 25, 2011

The writer is president of the Center for Medicine in the Public Interest and a former F.D.A. associate commissioner.