Contraception Edict and Obamacare

• 02.09.2012

http://spectator.org/archives/2012/02/09/the-contraception-edict-an-ass

The Contraception Edict: An Assault on Liberty


We're seeing Obamacare's future and how it works.

The Obama administration's decision to force religious institutions to cover contraception is a case study on how Obamacare and its implementation have politicized medical decisions. Here's how it works. First, health care choices are overruled if they do not flow from the state and do not require taking rights from one group to give to another in the name of fairness. Next, the same administrative apparatus engages in politicking and deal making to appease groups angered by the original decision.

The contraception mandate was issued unilaterally and without regard to the deep feeling and anger it would generate. Now the administration is rhetorically backpedaling and seeking to find a way to respond to the quickly spreading attacks on the action. Claims to the contrary, this was and is not about assuring all women have access to contraception. It was about eliminating the choices and overruling the preferences of one group to enforce the "rights" of another.

Now everyone is focusing on "accommodating" concerns that Obamacare would force employers and organizations to cover birth control. And in doing so, by turning an individual health choice into a government edict we must obey subject to Obamacare's equivalent of plenary indulgences -- a waiver -- we move one step away from liberty and closer to centralized control. That's why one idea for "accommodating" will never be implemented: 'Allowing' religious organizations and employers not to offer contraception as part of health insurance as long as they give employees who want it a choice of plans that do. That's because giving people choices of health plans also comes at the expense of enforcing everyone's "right" to medical care.

The contraception edict is but one of a series of Obamacare judgments that have angered millions of Americans because of its one size fits all nature. From mammograms, to coverage requirements, to end of life planning, the administration's actions rankle not because they are completely dumb (they usually are) but because they violate people's sense that such decisions should not be made by government and should not be based on meeting a political or policy goal.

The contraception decision is more disturbing than these previous enactments of Obamacare because freedom of religion is a deeply cherished freedom that allows us the liberty to establish a relationship with God, family, and lives in ways that government can never replace. As a result, more than any other action, the restriction of Catholic and other religious-sponsored organizations or employers to exercise choice reflects the belief that freedom of religion come at the expense of "reproductive rights of women" underscores how Obamacare regulators will restrict choice and access in the future. In this warped world, birth control medicines and devices are mandated and essential but not Avastin or genetic testing or treatments for cancer or rare diseases. Remember how the administration tried to make end of life planning a requirement? The inner logic of Obamacare is that life-saving therapies and choice inhibit the growth of the welfare state and the appropriate distribution of resources. It is the underlying rationale of the Independent Payment Advisory Board and the Patient Centered Outcomes Research Institute, which focus on "social decisions" rather than individual benefit, decisions that produce winners and losers based on a political calculus.

The action also exposes -- at the beginning of this presidential election season -- the fundamental view of liberty enshrined in Obamacare. Thomas Jefferson wrote "The God who gave us life, gave us liberty at the same time." Another political leader noted, "Liberty is precious. That is why it must be rationed." That was Lenin. You tell me which worldview shapes the contraception edict.

The Sinews of Safety

• 02.09.2012

In his 1946 Sinews of Peace speech Winston Churchill famously remarked, “From Stettin in the Baltic to Trieste in the Adriatic an iron curtain has descended across the Continent.

Has an iron curtain today descended on drug safety and quality on many other continents?

Word has it a new WHO study reports that only 20% of member nations have drug regulatory capacity to properly ensure the safety of their national drug supplies.  Yikes.

To paraphrase the British Bulldog, the safety of the world’s drug supply, ladies and gentlemen, requires a new unity from which no nation should be permanently outcast.

It’s time to actively and aggressively pursue FDA Commissioner Peggy Hamburg’s call for a regulatory Marshall Plan to help build (nation-by-nation) global systems for both quality and safety.

Unarguably, two of the most important health advances of the past 200 years are public sanitation and a clean water supply. Those achievements helped to control as many public health scourges as medical interventions helped to eradicate them. A high tide floats all boats.

Working together to raise the regulatory performance of all nations will help all nations (even the 20% deemed “capable” by the WHO) to create sound foundations to address a multitude of quality and safety dilemmas such the manufacturing of biosimilars, the control of API and excipient quality, pharmacovigilance and, yes, even counterfeiting.

With scare resources, perhaps the best place to start is by committing to common standards for data capture and reporting. After all, knowledge is power.

Difficult? To be sure. But, as Winnie reminds us, “A pessimist sees the difficulty in every opportunity; an optimist sees the opportunity in every difficulty.”

PDUFA in the Red Zone

• 02.07.2012

Bailing out drug shortages

• 02.07.2012

In Greece wise men speak and fools decide.
-- George Santayana

Poor Greece.

According to a new article in The Lancet:

The Greek Government's austerity drive has inadvertently triggered problems with the country's drug supply, causing shortages of hundreds of medicines.

But it’s not just Greece; drug shortages have been in the news in the United States and the EU. Also, in Saudi Arabia, some 2000 medicines are in short supply since 2008 and in Turkey some 350 medicines have been at risk of stock outs since arbitrary changes in pricing and reimbursement last November. 

Plainly speaking, artificially low prices cause drug shortages.

In the past few months, according to the PanHellenic Association of Pharmacists, 500 commonly used drugs are in short supply. Among them, there are drugs for hypertension, gastroenterological disorders, cancer, kidney diseases, and painkillers.

What’s causing Greek’s drug shortage problem? The same issue that causes it everywhere else – perverse market incentives.

In the United States, a government analysis of average sales prices showed that oncology sterile injectable drugs that experienced shortages since 2008 decreased in price from $56.17 per unit in Q1 2006 to $37.88 per unit in Q1 2011. Oncology sterile injectable drugs that have not experienced shortages have had relatively stable prices over this period.

Last year, the Greek government mandated lower drug prices to cut down its medical expenses. Medical expenses were €2·4 billion in 2004, €5·2 billion in 2009, and dropped to €1·65 billion in 2011, after the measure was taken.

However, the government's decision has fed the parallel trade market since
wholesalers prefer to sell their products in other countries where the profit is higher.

“Due to medicine shortage, the population's health is in great danger,” says Kostas Kouvaris, president of Pireaus Pharmacists Association. Theodore Abatzoglou president of the PanHellenic Association of Pharmacists points out that the recent government law for the prices of medicine has also caused hospitals to run out of drug stocks. And because of the extremely low prices set by the government, international companies are not interested in supplying Greek hospitals with medicine. Health institutes are now mainly being supplied by companies that sell generic drugs which, in many cases, represent older medical technologies.

But, generic drugs aren’t often what the doctor ordered.  Replacing an old generic drug for a modern innovator product may save a government money in the short term, but as patient outcomes worsen and hospitalization occurs, health costs skyrocket.

According to Greg Conko of the Competitive Enterprise Institute,

"Essentially all of the drug shortages that occur in the U.S. arise in the generics market, where profitability is fairly low … Compounding the problem is the fact that the 'buyers' of the drugs in question aren't patients but third-party payers -- insurance firms, pharmaceutical benefit managers, and government health programs -- all of which have a strong incentive to drive the prices paid for these products down as low as possible … So, for many of these drugs, the market can really only sustain a handful of manufacturers -- sometimes just one or two. So, when supply disruptions occur -- caused by a shortage of raw materials or more often a quality control problem in a manufacturing facility -- there aren't a lot of additional producers in the market to take up the slack.”

"The main cause of drug shortages is economic," says Mandy L. Gatesman, PharmD, of Virginia Commonwealth University in Richmond, and Thomas J. Smith, MD, of Johns Hopkins. "If manufacturers don't make enough profit, they won't make generic drugs.”

Let’s adopt a free-market solution and free physicians, pharmacists, and patients of the problem of needless drug shortages.

The government solution to a problem is usually as bad as the problem.              
-- Milton Friedman

No personalized medicine please, we're British

• 02.06.2012

NICE has issued draft guidance recommending against the use of three breast cancer diagnostics to guide decisions about chemotherapy use in women with estrogen receptor-positive, lymph node-negative, HER2-negative breast cancer.

According to NICE, the tests aren’t cost effective because evidence for their clinical efficacy is "limited."

But isn’t that the whole idea of personalized medicine?  And “limited” for whom?

Molecular diagnostics are what make medicines personal. Diagnostics are how drugs can be made safer through safe use. They make the “four rights” (right medicine for the right patient in the right dose at the right time) possible. And the four rights lead to lower costs through better outcomes.

Studies show that testing for HER2 breast cancer delivers savings that are 65 times its cost. That reimbursement should be based on value rather than activity is an essential paradigm shift.

This message is finally reaching a mass audience. Consider the recent USA Today story, “Genetic testing boosts efficacy in cancer care,” which reports that “tailoring cancer therapies to fit a person’s genetic makeup could spare thousands of patients from harmful side effects and save millions of dollars a year.”

Even NICE said the test's incremental cost-effectiveness ratio (ICER) -- aka cost effectiveness ratio -- per quality-adjusted life year (QALY) was "dominant" compared to current practice -- but the lack of data on analytical reliability and clinical utility made a recommendation for widespread use unwarranted “at this time.”

In other words, no reimbursement until more data is available. Whether or not that’s a convenient excuse or a scientifically based belief –it’s the wrong decision to dissuade the use of a validated diagnostic tool that saves lives though (1) more personalized care and (2) saves money by not spending it where it isn’t going to work.

NICE noted that most studies were retrospective, which it said is associated with increased bias compared to prospective trials. Maybe so.  But tell that to the 20 percent of women whose lives are at risk.

Research shows, not surprisingly, that many breast cancer patients who might benefit from Herceptin are not receiving it, while some women on the drug had never been properly tested.

"Our review of the literature suggests that there are important knowledge gaps regarding the real world use of HER2 testing and trastuzumab," said Elena Elkin, a researcher at Memorial Sloan-Kettering Cancer Center in New York. "Filling these gaps may help optimize limited healthcare resources and improve care for women with breast cancer."

But how will data be collected if these tests aren’t being used in regular clinical practice? (And they won’t be without reimbursement.) Are these approved and validated tests to be relegated to the narrow confines of lengthy clinical trials? What message does this send to the developers of advanced diagnostics – and for those who invest it such enterprises? What message does it send to pharmaceutical companies about the future of high-risk adaptive clinical trials? What message does it send about the future of targeted therapeutics?

To borrow an over-used adjective from the world of global climate change – what does this say about our ability to protect "sustainable" innovation?

Most disturbingly, what message does NICE’s decision send about medical ethics in the age of personalized medicine? Is this but the latest malignant manifestation of choosing short-term savings over long-term results, of cost-based choices over patient-centric care? Skimping on a diagnostic test today but paying for an avoidable hospital stay later is a fool’s errand, pernicious to both the public purse and the public health. The implications for the healthcare debate in the United States are uncomfortably obvious.

And considering the white-hot debate over the Komen Foundation/Planned Parenthood imbroglio – where’s the anger and indignation?

More research?  By all means.  Better-designed research? Absolutely. But by denying reimbursement for HER-2 tests until this research is designed, fielded, studied, reported and debated many lives will be lost and many millions of dollars wasted.

Another fine mesh you’ve gotten us into

• 02.03.2012

U.S. regulators should be able to block medical devices based on past products with safety issues, said House Democrats led by Representative Edward Markey of Massachusetts.

Current law requires the FDA to clear a device for sale if it’s “substantially equivalent” to a past device, known as a predicate. Markey’s bill would let the agency say no if the predicate, or past predicates in a series of equivalent devices, were removed from the market or if the agency were in the process of pulling it. It also would require companies to explain why their products are different from recalled versions.

The legislation also requires the FDA to review previously cleared products to determine whether any have recalls in their “device lineage.” A report would be due to Congress within three years.

Manufacturers “share Congressman Markey’s interest in ensuring the safety and effectiveness of medical devices,” said Wonderful Wanda Moebius, of the Advanced Medical Technology Association. “However, we believe FDA already has abundant authority to carry out its mandate and the burdensome provisions” in the bill “will not contribute to patient safety.”

In another piece of proposed legislation, U.S. Senators Bob Casey and John McCain introduced a bill that they said would streamline approvals. The legislation would ease the “burdensome review” the FDA requires to see if a new product is similar to one already on the market, the two men said in a statement.

“The FDA’s current approval process for medical devices can be cumbersome, inconsistent and far too lengthy for patients who need innovative technologies and for the companies that develop them,‘‘ said McCain, an Arizona Republican. Casey, a Democrat, is from Pennsylvania.

The bill would also address safety issues by ensuring that medical devices on the market before current safety rules existed are properly classified in a timely manner.

FDA Reform and Risk Perception

• 02.02.2012

According to an article in Reuters by Anna Edney, there has been a dispute among large and small biotech companies about how specific FDA reform legislation should be.  

The plan, drafted by Democratic Senator Kay Hagan of North Carolina, was supported by biotechnology companies to speed up approvals and make the process less expensive. It would have created a program with the flexibility to allow drugs to be cleared based on any testing that shows they may be effective. This may include early trial results, interim data and use of so-called biomarkers that measure the effects of a molecule on biological functions linked to a disease.

The unusual dispute pitted biotechnology companies struggling to finance extensive trials against larger drugmakers who often trade financial aid in return for sharing sales later, said Erik Gordon, a business professor at the University of Michigan in Ann Arbor.

“Smaller biotech companies often can’t raise enough money on their own to do the currently-required safety trials, so they want to dilute the rules to let them get approvals without having to give big pharma a cut of the action in return,” said Gordon, who is based in Ann Arbor, in an e-mail. “Big pharma says ‘don’t dilute safety measures for new drugs.’ That sounds better than ‘we want to keep our cut of the action.’”

I don't agree with Gordon.   He assumes that small and big firms have different interests.  In fact, the larger firms are partnering with or buying smaller biotech companies to sustain product development.  Why would a company invest in a product that will go through the FDA faster only to oppose reforms that would slow down approval? 

Rather,  larger companies view new approval measures and endpoints as causing uncertainty about how FDA will respond.  Smaller companies see the regulatory path as risky to begin with and regard specific requirements to approve based on a number of measures as reducing uncertainty.

It's a difference of perspectives, both of which have merit and are not at odds with the other.   I tend to side with the small companies and favor approval benchmarks that are based on a variety of response measures and post market experience.  But companies of all sizes and disease foci want to get highly effective products to market more quickly. 

My question is: how do we insure that what a product does -- as well as it's risks and benefits -- reflect consumer values more directly?

You can read the entire article here:  http://www.businessweek.com/news/2012-02-02/drugmakers-upset-approval-system-plan-biotechs-sought.html

Ready. Aim. PCORI.

• 02.02.2012

Representative Brett Guthrie (R-KY) introduced a bill (H.R. 3827) that would repeal the Patient-Centered Outcomes Research Institute and funding for comparative effectiveness research. The bill was referred to the Committee on Ways and Means, the Committee on Appropriations, the Committee on the Budget, and the Committee on Energy and Commerce. It was co-sponsored by Reps. Dan Benishek (R-Mich.), Joe Barton (R-Texas), Marsha Blackburn (R-Tenn.), Cathy McMorris Rodgers (R-Wash.) and Mike Rogers (R-Mich.).

Another AHRQ Report, Another Wasted Million Dollars

• 02.01.2012

Yet another AHRQ review of decades old data concluding that there is no gold standard evidence (randomized clinical trials) to determine whether stem cell treatments help or hurt kids who need organ transplants or who have juvenile diabetes.  

Other feautres of the study that now characterize most AHRQ 'research.'

No mention of genetic tests or variations that can stratify and optimize treatment.

Conducted by the same people who dole out money to other AHRQ grantees and sit on the PCORI board and who also sit on CER boards of HMOs. (Naomi Aronson).  If someone from a device or drug company was a co-author of a study funded by an agency whose decisions they would derive benefit from, Merrill Goozner and Gary Schwitzer (the wholly owned subsidiary of Health Dialog) would mutate into another life form.  Oh, I forgot to mention that AHRQ is also hiring drug reps to peddle this stuff to doctors and hospitals. 

How about some oversight on AHRQ's activities en route to cutting its budget or reordering it's mission?

http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productid=945

National Pharmaceutical Council Measuring Whether CER Measures Up to Personalized Medicine

• 02.01.2012

http://www.npcnow.org/Public/Newsroom/Press_Releases/2012pr/2012five_research_projects_pr.aspx