Latest Drugwonks' Blog
The Obama Watch
Hard on Drug Execs, Soft on Dictators
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.
-- Flip Wilson
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 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.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
