If You're Old, Black or Brown... You're Going Down

11/10/2009 05:35 PM |

The media's refusal to focus on the direct damage health care reform will inflict on the nation's poor and elderly is a disgrace, part of a willing effort to ignore the true human and economic cost of the proposals before Congress:

Here is an anecdote about how Medicaid performs today:

Holes in the safety net: Medicaid falls short just as some need it most
As need rises, patients struggle to find doctors who take the insurance plan

By Tom Curry and JoNel Aleccia
msnbc.com
updated 11:13 a.m. ET Aug. 11, 2009

GOSHEN, Ind. - For weeks now, 2-year-old Ashley Soto's hair has been falling out in clumps and bunches.
Doctors at the Maple City Health Care Center, a neighborhood clinic where the toddler's family receives most care, couldn’t diagnose the problem. The child needed to see a specialist, but no local dermatologist would agree to accept Medicaid, the government’s safety net plan. Instead, Antonia Mejorado, 33, has to drive nearly two hours to see a dermatologist willing to treat her daughter's potentially serious illness.

“There is not a doctor around here that takes Medicaid,” said Mejorado, whose husband, Osvaldo Soto, 33, has recently seen his hours cut to almost nothing at a local mechanic shop....

About one in five physicians say they are not accepting any new Medicaid patients, largely because of low payments or delays in reimbursements, according to the Center for Studying Health System Change in Washington, D.C.

‘A lot of things are scary’
Ashley Soto, the 2-year-old with unexplained hair loss, is eligible for Medicaid because she was born in this country. The child’s parents, who are from Mexico, are not. Her mother worries that a serious diagnosis could mean more long days traveling the 75 miles between Goshen and Michigan City, Ind.

“A lot of things are scary — not having a doctor nearby in case something happens to her,” said Mejorado, who is also the mother of three other children ages 17, 14 and 14 months.
http://www.msnbc.msn.com/id/32127373/ns/us_news-the_elkhart_project/
Things are going to get a lot scarier....

From an AEI Report

Medicaid: The Forgotten Issue in Health Reform
By Robert B. Helms
AEI Health Policy Outlook, November 2009

"...the distribution of federal Medicaid expenditures per poor person ranges from a low of $2,014 in Nevada to a high of $7,753 in Maine, an almost fourfold difference. One of the objectives of the original Medicaid legislation was to allow states the flexibility to design a Medicaid program that reflected the preferences of their voters and their willingness to be taxed to support the program. Some states obviously prefer more extensive programs than others, but this choice has been influenced by the availability of federal, open-ended matching. This has had the effect of expanding the program in all states, while expanding it relatively more in higher-income states. The availability of federal funds has also reduced the incentive for the states to design cost-effective programs or to reduce the level of fraud and abuse.

The politics of fixing this conundrum are indeed daunting since it pits one region of the country against another, but to ignore this effect means Medicaid will continue to do a poor job of helping the vast majority of the poor and disabled. Expanding Medicaid eligibility to more adults and to higher-income families with 100 percent federal financing may have a marginal effect to narrow this distribution, but it will not change the basic incentives now built into the system of federal financing."

And efforts to equalize Medicaid spending by "redistributing" resources to the lower cost regions will only hurt the concentration of urban poor in rich states... The same goes for efforts to punish doctors who spend more per patient than 10 percent of the lowest spending docs... (Features in health reform proposals in both houses)

And we are going to increase health care coverage for 50 percent of the uninsured in this fashion?

From the MSNBC report:

"Medicaid reimbursement rates can be as much as 40 percent lower than those for private insurance, according to John Holohan, the director of the Health Policy Research Center at The Urban Institute, a Washington think tank.

Michigan, for example, recently announced a 4 percent cut in payments to doctors, dentists and hospitals who treat Medicaid patients. The move prompted a new exodus of doctors who’ve decided to limit care.

"I love what I do, but I can't keep getting cuts from Medicaid," Dr. John Pfenninger, a family physician in Midland, Mich., told the Associated Press. "It's time to say no. "

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Georgia on my mind

11/10/2009 07:39 AM |

From today's edition of the Atlanta Journal-Constitution:

Are higher co-pays the answer to controlling medical costs?

NO: Discouraging treatment is shortsighted and leads to more costs.

In the current national health care debate, let’s hope we never hear the words, “As Georgia goes, so goes the nation.”

Since 2005, Georgia politicians have been conducting a dangerous penny-wise, pound-foolish experiment with its state health program by hiking co-pays for brand-name prescription medications.

The results of that policy have been sicker, less productive state employees. These Georgians end up consuming more and costlier health care during the course of their lives, as their neglected conditions worsen.

The lesson here is that higher co-pays discourage patients from getting the treatment they need — especially when they reach upwards of $100.

Just consider what Daniel M. Hartung of Oregon Health & Science University calls the “co-pay effect.”

Professor Hartung and his colleagues analyzed the effect of even a small co-payment — $2 for generic drugs and $3 for brand-name drugs — for those pharmaceuticals that were available to Oregon Medicaid enrollees in 2003.

The co-pay fees were not required for patients who were unable to pay. The researchers examined pharmacy claims data on about 117,000 Medicare enrollees with conditions like depression, schizophrenia, respiratory disease, cardiovascular disease and diabetes.

They found that the patients’ overall use of prescription drugs decreased by about 17 percent after the introduction of the co-pay policy.

It should come as no surprise that any policy that encourages patients to stop taking their prescription drugs is a recipe for disaster.

There is already a growing national trend of Americans not adhering to their prescribed drug regimens.

A study by Wolter Kluwer Health found that fewer and fewer Americans are even bothering to fill their prescriptions.

In fact, during the fourth quarter of 2008, American patients neglected to fill 6.8 percent of their brand-name prescriptions — a 22 percent increase when compared to the previous quarter.

This practice — often known as prescription drug “nonadherence” — can have serious repercussions on a patient’s health.

For example, hypertensive patients who do not take their prescribed medicines as directed suffer 5.4 times as many poor clinical outcomes as those who do.

And poor outcomes are 1.5 times more common for heart disease patients who do not take their meds regularly.

This adds an additional $100 billion to $300 billion in health care costs each year.

The trend has been perpetuated by the fact the Americans with private health insurance have found themselves paying more for prescription drugs in recent years.

Why? Because insurance companies are paying less. In 2000, people under 65 with private health insurance paid 37.2 percent of their prescription drugs costs out of their own pockets.

Many Americans mistakenly believe that this increase in out-of-pocket expenses is the result of higher drug costs. The data reveal otherwise.

In fact, the growth in prescription drug co-payments outpaced the growth rate of prescription drug prices four to one.

It’s easy to see why plans to increase the co-pays for Medicare beneficiaries will also have serious adverse effects on the health of our seniors, as well as on our health care system as a whole.

Unable to afford their prescriptions, many Medicare enrollees will begin treating strict obedience to their drug regimen as a luxury, not a necessity.

As more and more seniors choose to abandon their treatment, health care outcomes will suffer, as prices soar even higher.

Making health care decisions based solely on cost is a losing strategy over the long term for both the state and for the health of its residents.

But maybe those are the kind of shortsighted, budget-driven results you get when cost-over-care bureaucrats run your health plan.

Peter J. Pitts is president of the Center for Medicine in the Public Interest and a former FDA associate commissioner.

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Social Media Listeners

11/09/2009 06:19 PM |

We've discussed the speakers at Thursday/Friday's Part 15 hearing on social media -- and now we know who will be doing the listening (and questioning) from the FDA side:

• Thomas W. Abrams - Director, Division of Drug Marketing, Advertising, and Communications (DDMAC) - Center for Drug Evaluation, and Research (CDER)
• Kathryn J. Aikin - Social Science Analyst, DDMAC - CDER
• Rachel E. Behrman - Deputy Director, Office of Medical Policy (OMP) - CDER
• Gerald Dal Pan - Director, Office of Surveillance and Epidemiology - CDER
• Kristin Davis - Deputy Director, DDMAC - CDER
• David J. Horowitz - Assistant Commissioner for Policy, Office of Policy, Planning, and Budget - Office of the Commissioner
• Ele Ibarra-Pratt - Branch Chief, Advertising and Promotional Labeling Branch - Center for Biologics Evaluation Research
• Jean-Ah Kang - Special Assistant to the Director, DDMAC - CDER
• Sharon Kapsch - Chief, MDR Policy Branch - Center for Devices and Radiological Health (CDRH)
• Dorothy R. McAdams - Supervisory Veterinary Medical Officer, Division of Surveillance - Center for Veterinary Medicine
• Seth S. Ray - Associate Deputy Chief Counsel for Drugs and Biologics - Office of the Chief Counsel
• Robert Temple - Director, OMP - CDER
• Deborah Wolf - Regulatory Counsel, Office of Compliance - CDRH

It's almost showtime.
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Forced Redistribution of Healthcare Services

11/09/2009 11:43 AM |

The goal of the HR 3200 is to collectivize health care delivery by increasing taxes on businesses and individuals, the destruction of the private health insurance, including Medicare advantage and the redistribution of medical services along geographically regions.

Yes, the government will be empowered to redistribute health care spending along geographically areas. Doctors in the 20 percent of counties that have the lowest medicare expenditures will get a 5 percent bonus in the House bill. The House bill also propose to revamp hospital and physician fees to equalize geographical payment levels with the goal of forcing down higher spending areas to the lower spending regions. The impact on innovation, access to care and health will be devastating. Such efforts ultimately fail. Both Canada and the UK have substantially increased health care spending (at a faster rate than we have) and still have wide regional disparties in expenditures and outcomes. In the meantime, health outcomes in the US are better than they are in Canada or the UK for cancer and heart disease, the leading causes of death.
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Off-Label Fable

11/09/2009 08:19 AM |

Two new articles on the issue of off-label promotion.

The first, courtesy of Bloomberg.com, is far from courteous or unbiased.  Consider this quote from Jerry Avorn, a professor at Harvard Medical School and regular critic of the industry:

“Marketing departments of many drug companies don’t respect any boundaries of professionalism or the law.”

Untrue and unfair. That’s a pretty broad brush – but Dr. Avorn has never worried about the unintended consequences of hyperbole.

The Bloomberg article continues, “The widespread off-label promotion of drugs is yet another manifestation of a health-care system that has become dysfunctional.”

That’s outside of any citation – that’s just the reporter talking.  Bad journalism.

And then back to Jerry Avorn:

“It’s an unbearable cost to a system that’s going broke. We can’t even afford to pay for effective, safe therapies.”

Now the article is confusing the issue of off-label promotion with off-label use.  And that’s a much clearer articulation of the article’s broader agenda.

The complete Bloomberg article can be found here.

A much better omnibus discussion of off-label promotion can be found in the November issue of Nature Biotechnology. An excerpt:

“… on October 2, Allergan, in Irvine, California, filed a lawsuit against the FDA seeking to challenge off-label regulations. Allergan contends that agency rules stop them from sharing safety information about off-label use of approved drug Botox (Clostridium botulinum toxin). The company contends that Botox is effective for as-yet unapproved uses in spasticity, and given that physicians are already using it for that purpose, it is important to communicate information to reduce the risk of adverse events. Indeed, Allergan claims the regulations violate the right to free speech under the First Amendment of the US Constitution. But it also stands to reason that if the information it seeks to communicate was in the literature, Allergan would not have needed to file the suit.”

The complete Nature Biotechnology article can be found here.

Also quoted in the Bloomberg article newbie FDA employee Peter Lurie, who makes an important point, “Most physicians don’t keep track of FDA-approved uses of drugs.”

All the more reason for a robust and expanded “safe use” program by the FDA. 

Label detailing aids anyone?

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Viral Media

11/06/2009 08:32 AM |

And about those “Canadian” websites …

From today's New York Times:

F.D.A. Fighting False Online Claims About Swine Flu Treatments

You can buy healing gels that “create a barrier between you and the potentially deadly virus now spreading across the globe.” Or “ionic silver” that kills every known pathogen, germ, bacteria, virus or fungus within six minutes. “Spray Swine Flu . . . Gone . . . with ionic silver on your hands,” one ad claims.

Now that the White House has declared swine flu a national emergency, and with the H1N1 vaccine in short supply, many Web sites have been peddling swine flu nostrums.

The Food and Drug Administration has identified 140 different dubious products sold online and has sent letters to 75 manufacturers. It is violation of federal law to market products that claim to prevent or treat H1N1 and that have not been approved by the F.D.A.

The agency has gone after sellers of gloves, inhalers, masks, shampoos, herbal extracts, air fresheners and an array of vitamins that make claims about fighting swine flu. Some of the Web sites were fly-by-night operations that have since closed down.

The complete New York Times story can be found here.

Food for thought for those who continue to foolishy call for risky drug importation schemes.

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From Gidget to Widget

11/05/2009 08:23 AM |

Some interesting findings from market research firm Verilogue.

The first is that, of 12,500 measured patient-doctor conversations in 2008, the research firm found only 23 requests for specific drugs.

That’s somewhat counterintuitive considering all the punditry and political bloviation about DTC advertising driving “unnecessary” prescribing. But it’s not at odds with studies (including those done by the FDA) that show that about 6% of all doctor visits in the United States are a direct result of a patient (also known as a consumer) having seen a DTC ad. Taken together, these results demonstrate that DTC ads drive patients to visit their doctors (a good thing) and that those visits do not result in inappropriate pressure to prescribe.

The other Verilogue item of interest is that the most frequently cited drug by patients was Boniva. The Boniva DTC campaign, features actress – and honest-to-goodness osteoporosis sufferer -- Sally Field.

Supportive data, via IMS Health, shows that prescriptions for Boniva were up 11% last year, and sales of the drug grew 25%, to $675.6 million. The message, according to Richard "Erik" M. Gordon, assistant professor at the University of Michigan's Ross School of Business, is “authenticity.” Gordon says that, "People want to believe a celebrity isn't just doing this because they were paid a pile of money."

Maybe so.  But, in the 21st century, solid healthcare communications is a lot more complicated than finding a celebrity sufferer --  it’s about moving from “Gidget” (the role that initially made Ms. Fields a household name) to “Widget” (social media tools that communicate healthcare messages – pharmaceutical and otherwise – in more immediate, trusted, peer-to-peer ways). Friends and neighbors.  Now that’s star power.

Bouquets to Boniva for doing it right.  And brickbats to Senators, such as Minnesota's Al Franken, who believe that DTC is deliterious to the public health despite mountains of evidence to the contrary.
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A Clap of the Dose

11/04/2009 06:58 PM |

A safer drug is a drug that is used appropriately.

FDA Unveils Safe Use Initiative that Targets Preventable Harm from Medication Use
Agency also releases drug dosage guidance for measuring devices included with OTC medications

The U.S. Food and Drug Administration today announced the Safe Use Initiative, a program aimed at reducing the likelihood of preventable harm from medication use.

“Too many people suffer unnecessary injuries from avoidable medication misuse, errors and other problems. The FDA is launching the Safe Use Initiative to develop targeted solutions for reducing these injuries,” said FDA Commissioner Margaret A. Hamburg, M.D.

Millions of people are harmed every year from inappropriate medication use. Many injuries occur as a result of incomplete access to information about a drug, a patient, or the patient’s condition.

Other preventable sources of harm include unintentional misuse of medications, medication abuse, and attempts at self harm. Unintended exposure to prescription medications such as opioid drugs can cause harm, even death, in a single dose, if taken by someone other than the patient who was prescribed the medication.

“Only through coordinated interventions across all sectors of the health care system can we substantially reduce preventable injuries from using medications,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. "All participants in the health care community have a role to play in reducing the risks and preventing injuries from medication use.”

More detailed information on the new program was contained in a report, titled, “FDA’s Safe Use Initiative – Collaborating to Reduce Preventable Harm from Medicines.” The report was released by Drs. Hamburg and Woodcock at FDA’s annual Science Writers Symposium at the agency’s White Oak Campus in Silver Spring, Md.

As outlined in the report, the FDA intends to collaborate with health care professionals and other stakeholders to identify drugs and drug classes that are linked to preventable harm. A list of specific problems, cross-sector interventions for reducing harm from these problems, and the metrics for success will be developed.

The report highlights several risk-reduction projects that may benefit from Safe Use collaborations, including evaluating consumer medication information, communicating about the risk of inadvertent overexposure to acetaminophen, implementing safeguards against surgery fires caused by alcohol-based surgical preps, and avoiding contamination of multiple use medication vials.

To further advance the Safe Use Initiative, the FDA intends to hold a series of public meetings to gather feedback as the candidate list is being developed and will open a public docket to receive comments on the report and proposed candidate cases.

The agency also today made public new FDA guidance for companies that manufacture, market, or distribute over-the-counter liquid medications packaged with dosage delivery devices such as calibrated cups, droppers, syringes and spoons.

The guidance document, titled “Dosage Delivery Devices for OTC Liquid Drug Products,” was posted for advanced viewing in the Federal Register today.

Accidental overdoses can be caused by dosage delivery devices that are unclear or are inconsistent with the labeled dosing instructions.

"This new drug dosage guidance document is an example of steps that can be taken to ensure safer medication use,” said Woodcock. “Many accidental overdoses result from confusion about exactly how much of a drug to take. Better measuring devices will help patients, parents, and other caregivers use the right amount of these medications – the safest and most effective dose – especially for children.”
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Pig & Whistle

11/03/2009 04:38 AM |

From today's New York Post and the pen of CMPI's very own Bob Goldberg:

WHY YOU CAN'T GET SWINE FLU VACCINE

The shortage of swine-flu vaccine results not from drug- company greed or outsize demand but almost entirely from the government's decision to pander to unfounded and unscientific fear.

As The Wall Street Journal reported last week, the US government set out to have the H1N1 vaccine produced largely in single-dose syringes -- a demand that has set back production considerably, because multidose vials are far easier to make.

And the only reason to seek single-dose production was to please people needlessly worried about the preservative thimerasol, which is used to provide multiple doses of the vaccine. The fear -- utterly groundless and repeatedly debunked is that thimerasol can cause autism and other neurological disorders in infants and other young children.

If not for that decision, we'd have more than enough vaccine. Instead, because the government yielded to pressure from antivaccine fringe groups, we're behind the curve on protecting millions of children from swine flu.

It's a tribute to the effectiveness of pandemic planning and the introduction of new technologies that the nation will likely have plenty of H1N1 vaccine within a month.

Flu strains don't show up when expected. H1N1 was supposed to arrive along with the "regular" seasonal flu, but it began three months early. Using genomic technologies, public-health officials and such vaccine developers as Novartis and Sanofi-Pasteur isolated the H1N1 strain and identified antibodies for production in record time.

Yet, despite this technological ability to adapt quickly to a pandemic threat, our system has been hamstrung by pseudoscience evangelists.

The thimerasol scare, disproved time and again, persists in part because the same public-health entities that encourage immunizations have made significant concessions to small, persistent fear-mongering activist groups.

In 1999, the Food and Drug Administration and the Centers for Disease Control called for the maximum removal of thimerasol from vaccines -- even though both stated there was no scientific evidence of side effects.

Beyond pressuring the government, antivaccine activists have had an indirect effect on the private sector's ability to meet the need for vaccines. Lawsuits in the '80s claimed that DTP (diphtheria, pertussis, tetanus) vaccine caused brain damage; the court actions scared off investment in production facilities using the new recombinant technologies.

As a result, the number of firms producing DTP and other vaccines plummeted. In 1980, 18 companies made vaccines; by the end of the decade, only four were left.

The loss of innovation, investment and profitability in the vaccine industry means we have a gene-based development process for the 21st century -- but a production process that hasn't changed in the last 100 years.

We reap the consequences of that antiquated production process today -- visible on signs posted outside local drugstores and clinics across the country: "Out of H1N1 Vaccine."

But production hasn't been the only casualty of antivaccine hysteria. Since the 1980s, many children have been left unprotected against diphtheria, pertussis and tetanus. How many hundreds of thousands of American children have suffered, from pertussis or other diseases, because of a crackpot minority? How many more will suffer during the current shortage?

By bowing to the unfounded concerns of a few, our government has compromised the safety of many. It's done an admirable job, so far, of communicating with the public about the H1N1 threat and boosting immunization rates. But perhaps its most important job moving forward is to properly align policy with established scientific opinion and the public's best interests.

Twisting the canons of science endangers the public's health and exposes our children to real harm.

Robert Goldberg is vice president of the Center for Medicine in the Public Interest. rgoldberg@cmpi.org

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Comparative Comparisons

11/02/2009 06:44 AM |

Ah -- the vicissitudes of sausage making.

According to Andrew Dawson, staffer for the House Ways and Means Committee, “The final CER  product - whatever comes out of the Senate, whatever comes out of the House - they are different enough that where we end up in a conference report will be somewhere in the middle."

When Mr. Dawson refers to "CER," he means Comparative Effectiveness Research -- aka cost effectiveness, aka clinical effectiveness, aka healthcare technology assessment.  But it's important to recognize that these are not all synonyms. (For example, in the long ago and forgotten stimulus package, $1.1 billion was set aside for clinical effectiveness research.)

The Senate Health, Education, Labor and Pensions Committee's reform package would create a new center in the HHS Agency for Healthcare Research and Quality to oversee CER. The melded House health reform bill, unveiled Oct. 29 would also create a center within AHRQ, though supported by a combination of public and private funding and receiving advice from an independent stakeholder commission.

Another key pending issue is how research data generated by CER may be used. The House has previously added language stating explicitly that data "may not be used to deny or ration care." The Senate Finance Committee version lets CER data be used in Medicare coverage decisions, though only providing several criteria are met and a single CER study is not the only basis for a decision.

The Congressional Budget Office has scored the CER provisions of the revised House bill as lowering Medicare outlays by $100 million from 2010 through 2019, but increasing non-Medicare outlays by $1.2 billion during the same period.

How can CBO score CER studies – that (1) according to the revised House bill aren’t supposed to be used “to deny or ration care” and (2) don’t exist yet?  Hmm.

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The Tweet Smell of Success

10/30/2009 10:41 AM |

The running joke about Part 15 hearings is that they're so named because there are generally only 15 interesting minutes.  Not so for the upcoming Part 15 hearing on social media.  Good topic.  Timely topic.  Sexy topic.

And the list of those testifying is also a guarantee of better-than-usual fare.  That list (subject to change) can be found here.

Pharmaceutical marketers and the FDA are in a tough spot when it comes to social media.  On the one hand, both recognize the importance of and opportunity in it.  It's where the people are.  It's where the action is.  On the other hand there are those pesky regulatory concerns.

To quote that well-known FDA pundit -- Buffalo Springfield -- "There's something happening here.  What it is ain't exactly clear."

And clarity (qua predictability) is the key to success for social media to become a powerful tool in advancing both marketing aims as well as the public health.  Not mutually exclusive goals -- and not necessarily in that order.
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I'm just riled about Harry

10/30/2009 08:52 AM |

A passel of smarts from the pen of Kim Strassel:

Regarding Harry

The public option diverts attention from the legislation's real faults.

By KIMBERLEY A. STRASSEL

You couldn't swing a cat this week without hitting a discussion of the public option. Somewhere, in some Capitol office, Senate Majority Leader Harry Reid is grinning.

Two weeks ago, the subject of a government-run insurance plan was a sore point with the Nevadan. He didn't have the votes for it, his base was bitter, and he didn't want to talk about it. This week, a transformed Mr. Reid devoted an entire news conference to it. Americans support the public option! His caucus supports a public option! He supports a public option! The public option is in! No problem!

In the real world, this kind of behavioral shift lands you in a psych ward. In Washington, the press just marked it down to forces bigger than Harry. The majority leader had been pushed into a public option by his liberal members, we were told. Chuck Schumer was scarier than Ben Nelson. The Huffington Post was even scarier than Chuck Schumer. Poor Mr. Reid, clucked observers, had been backed into a corner.

Maybe. Then again, maybe he is majority leader for a reason. Maybe Mr. Reid didn't just wander out of the Nevada desert. Maybe he has a plan. Maybe, just maybe, he sees a big upside in turning the public option into the centerpiece of the health-care debate. After all, what does he have to lose?

Up for re-election next year, Mr. Reid is facing Nevada polls that suggest he's lost most voters outside his base. His base too, was slipping, with Moveon.org making him a punching bag for not embracing the public option. With this week's announcement, he is once again the hero of the left, and has that baboon off his back.

Who knows? It might even work. Mr. Reid included the fig leaf of an "opt-out" for states that don't want the public option. It's a ruse, but it might provide cover for votes. If not, he's got room to maneuver. There's the "opt-in" alternative, which even some Republicans claim to like. There's the fall-back "trigger," which re-earns him Olympia Snowe.

And if it doesn't fly, well, is that so bad? Mr. Reid can still say he gave it the varsity try. He'll get it to the floor and let those swing-state Democrats amend the public option away. Not his fault! What he also knows, even if the press doesn't, is that for all the big talk of his liberal members, they are the more likely to give way. Even without a public option, this bill is a big step toward a single-payer system. And it isn't as if any of them risk losing their seats by voting "only" for a $1 trillion health expansion.

Better yet, by turning the public option into the big, bad bogeyman, he makes it more likely he'll snag those swing-state votes in the end. Nebraska's Mr. Nelson, Arkansas's Blanche Lincoln, Indiana's Evan Bayh—they can all claim victory for stripping the bill of a national insurance plan, then feel comfortable voting for all the tax hikes and Medicare cuts that remain.

Speaking of tax hikes, premium jumps and Medicare cuts, notice how nobody is today talking about them? Mr. Reid surely has. The public option might be controversial in D.C., but the majority leader knows most of the country doesn't understand it, or assumes it doesn't apply to them. Most Americans already have health care that they like, and polls show their real fear is that this experiment will leave them paying more for less. This, not the public option, is ObamaCare's exposed jugular.

The insurers get this, which is why (as they now try to bottle the genie they helped loose) they are issuing reports on how "reform" will double or triple premium prices. It is why America's Health Insurance Plans, the lobby group, has run ads in swing states warning about huge cuts to Medicare Advantage. Some of the grass roots get it, too, which is why Americans for Tax Reform is now live on TV in Nebraska noting Sen. Nelson has signed its taxpayer pledge and that he'd violate it by voting for the bill's nearly $500 billion in tax increases.

If Mr. Reid had pulled the plug on the public option, these highly unpopular policy issues would be front and center. As it is, the public-option sideshow is sucking up all the air, and will continue to. It even overshadowed liberal divisions, such as union pushback on Cadillac-plans taxes. Maybe, just maybe, Mr. Reid likes it that way.

Granted, this is the cynic's view of Democrats' health-care strategy. Mr. Reid did, after all, goof last week, failing to round up the votes to pass his party's proposed "fix" to Medicare reimbursement rates. Maybe he doesn't know which way is up. Maybe he is taking a flier.

Then again, anyone who has watched this debate has earned the right to cynicism. Democrats are determined to get a health bill, and Mr. Reid is no rube. His opponents—those trying to save the country from this wreck of a bill—would be wise not to forget it.

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Model health care reform on Medicare Part D

10/29/2009 02:54 PM |

Congress and the president need to craft new legislation that actually addresses the insurance needs of the American people and is based on the kind of post-partisan cooperation Obama promised in the campaign. A new insurance program modeled on Part D could unleash competitive forces that have already proven to drive down costs and expand coverage.

PETER J. PITTS is president of the Center for Medicine in the Public Interest and a former FDA Associate Commissioner.
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Pandemic Planning: Learning From History

10/28/2009 11:43 AM |

With all the bad news (or rather reporting and opining about the bad news) regarding vaccine "shortages" it is important to put into perspective how far we have come and how well we are prepared for a highly unpredictable and relatively lethal form of flu. Contrary to the uninformed claims of people like Shannon Brownlee who insist that vaccines will not reduce mortality by 50 percent in high risk populations (only look at averages is misleading and deliberately so Shannon), the vaccine for swine flu delivered to people who need it most, (kids, pregnant women and immune compromised people) will be life saving. And we have a plan that -- like any plan -- will change on contact but will do what it is supposed to do because it has learned from past pandemic response efforts.

The following testimony delivered by Paul Offit in 2006 about how an outbreak of Asian flu was prevented in 1957 provides a perspective on how well we are doing today. Now if only CDC would tell the anti-vaccine and thimerasol scaremongers to go shove it!

www.fas.org/irp/congress/2006_hr/biodefense.html

PHILADELPHIA
Dr. Offit. Good morning, Senator. My name is Paul Offit. I am Chief of Infectious Diseases at Children's Hospital in Philadelphia and a former member of the Advisory Committee on Immunization Practices to the CDC.

I would like to talk briefly today about an event that occurred 50 years ago in 1957, the only time in our history that we have made influenza vaccine in advance of a pandemic, because I think there are several lessons that can be learned from that event. On April 17, 1957, Maurice Hilleman, a scientist working at the Walter Reed Army Medical Research Institute, read an article in the New York Times titled ``Hong Kong Battling Influenza Epidemic.'' The article stated that 250,000 people, 10 percent of the entire population of Hong Kong, had suddenly come down with the flu.

Hilleman found that this outbreak signaled--feared that this outbreak signaled the start of the next pandemic. So the next day he sent a telex to the Army's 406th Medical General Laboratory in Zama, Japan, asking them to send him specimens from people infected with the virus. The first specimens arrived 1 month later on May 17, 1957.

For 5 days and nights, Hilleman worked to determine whether the influenza virus circulating in Hong Kong could be a pandemic strain. He tested sera from members of the American military and adults in the general population, but could not find anyone whose immune systems had seen this virus before. Hilleman then sent the virus for testing to the United States Public Health Service, the Commission on Influenza of the Armed Forces Epidemiological Board, and the World Health Organization. They found that only a handful of people in the United States and the Netherlands had antibodies to the virus. Because few people in the world had antibodies to stop it, the influenza virus circulating in Hong Kong in 1957 could spread from one country to the next unchecked.

Hilleman then sent the virus, now called Asian flu, to six American-based companies. He figured that if he were to have any chance of saving lives companies would have to make and distribute tens of millions of doses in only 4 months. Hilleman sped up the process by ignoring the Division of Biologic Standards, the Federal agency responsible for regulating vaccines.

He also asked vaccine makers to advise chicken producers not to kill their roosters, even though it was late in the hatching season. He knew that production of tens of millions of doses of vaccine would require at least 200,000 eggs a day.

As predicted, in September 1957 Asian flu entered the United States from both coasts. The first laboratory-proven cases occurred aboard naval vessels in Newport, Rhode Island, and San Diego, California. The first outbreak was triggered by a San Diego girl who carried the virus to an international church conference in Grinnell, Iowa. The second occurred in Valley Forge, Pennsylvania.

Companies made the first lots of Asian influenza vaccine in June 1957 and vaccination began in July. By late fall, 40 million doses were distributed in the United States. Within a few months, influenza infected 20 million Americans. 70,000 died from the disease. Worldwide, the pandemic killed at least 4 million people.

The Surgeon General of the United States, Leonard Burney, later said, quote: ``Many millions of persons we can be certain did not contact Asian flu because of the protection of the vaccine.'' For his efforts, Maurice Hilleman won the Distinguished Service Medal from the American military.

Several features of this outbreak and our response to it are instructive. First, Hilleman had to rely on reading an article in a newspaper to know what was happening in Southeast Asia and he had to wait 1 month before he received samples of the virus. Today the international community of scientists, clinicians, and public health officials, armed with sophisticated virological techniques, are much better at surveillance of outbreaks and characterization of possible pandemic strains.

Second, Hilleman called on six U.S.-based influenza vaccine makers. Today no U.S.-based companies make the inactivated vaccine. Sanofi Pasteur has a manufacturing facility in Swiftwater, Pennsylvania, but is not a U.S.-based company.

Third, Hilleman had to rely on eggs to produce vaccines. Recognizing that egg production is unreliable, the President's pandemic flu plan has effectively encouraged vaccine makers to gear up facilities to grow influenza virus in mammalian rather than avian cells. For example, GlaxoSmithKline recently purchased a manufacturing facility in Marietta, Pennsylvania, and MedImmune, the makers of a live attenuated influenza vaccine, will manufacture vaccine in mammalian cells in Maryland. Given that the influenza vaccine is generic and inexpensive, it is unlikely that vaccine makers would have done this without financial encouragement.

Fourth, Hilleman completely ignored the Division of Biologic Standards, the Federal agency responsible for regulating vaccines. At the time vaccine regulation was in its infancy, regulated by a small division within the National Institutes of Health. Today vaccines are regulated by the Food and Drug Administration and they do an excellent job. Vaccine regulation I think has helped to make vaccines arguably the safest and best-tested products that we put into our bodies. But the process is slow and if we are to make vaccine quickly the regulatory process would have to be streamlined significantly.

Fifth, Hilleman was a committee of one. He took responsibility for shepherding each step of the process. It would be impossible for him to do that today, but it would certainly be of value for one central agency to be held accountable for making sure that vaccine was made, tested, and distributed quickly and efficiently.

Sixth, Hilleman never considered liability protection for vaccine makers. In 1957 pharmaceutical companies were not held liable if they were not negligent in the production or design of their product. Ironically, the birth of liability without negligence for pharmaceutical companies began with a jury verdict against a vaccine maker, Cutter Laboratories, only a few months later. However, it is clear that vaccine makers would not make a pandemic flu vaccine today without substantial protection from frivolous litigation.

Thanks for giving me an opportunity to speak before this committee.

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The Best Article on Healthcare Reform...

10/28/2009 09:50 AM |

Public plan mirage
By Robert J. Samuelson
Monday, October 26, 2009

In the health-care debate, the "public plan" is all things to all people. For supporters, it would discipline greedy private insurers and make health-care coverage affordable. For detractors, it's a way station on the path to a single-payer insurance system of government-run health care. In reality, the public plan, also known as the public option, is mostly an exercise in political avoidance: It pretends to control costs and improve access to quality care when it doesn't.

As originally conceived by Yale political scientist Jacob Hacker, the public plan would be a government-created, nonprofit insurance company providing Medicare-like coverage to the under-65 population. But unlike Medicare, benefits would be paid for mainly by premiums -- not taxes. Americans could buy coverage from the public plan or a private insurer.

Competition and choice would increase, say liberals. Facing the low-cost public plan, private insurers would hold down their own premiums, the argument goes. Health-care costs for everyone would moderate. Government subsidies to provide universal coverage would be cheaper. By some estimates, Medicare's administrative costs are only 3 percent of spending, compared with 13 percent or more for private insurers. A new public plan is widely presumed to enjoy an advantage in overhead.

Nonsense, retort critics. The public plan's low costs would be artificial. Its main advantage would be the congressionally mandated requirement that hospitals and doctors be reimbursed at rates at or near Medicare's. These are as much as 30 percent lower than rates paid by private insurers, says the health-care consulting firm Lewin Group. With such savings, the public plan could charge much lower premiums and attract lots of customers. But health costs wouldn't subside; hospitals and doctors would offset the public plan's artificially low reimbursements by raising fees to private insurers, as already occurs with Medicare. Premiums would increase because private insurers must cover costs to survive.

As for administrative expenses, any advantage for the public plan is exaggerated, say critics. Part of the gap between private insurers and Medicare is statistical illusion: Because Medicare recipients have higher average health expenses ($10,003 in 2007) than the under-65 population ($3,946), its administrative costs are a smaller share of total spending. The public plan, with younger members, wouldn't enjoy this advantage.

Likewise, Medicare has low marketing costs because it's a monopoly. But a non-monopoly public plan would have to sell itself and would incur higher marketing costs. Private insurers' profits (included in administrative costs) also explain some of Medicare's cost advantage. But profits represent only 3 percent of the insurance industry's revenue. Moreover, accounting comparisons are misleading when they don't include the cost of Medicare's government-supplied investment capital. A public plan would also need investment capital. And suppose the public plan suffers losses. Congress would assuredly bail it out.
The promise of the public plan is a mirage. Its political brilliance is to use free-market rhetoric (more "choice" and "competition") to expand government power. But why would a plan tied to Medicare control health spending, when Medicare hasn't? From 1970 to 2007, Medicare spending per beneficiary rose 9.2 percent annually compared to the 10.4 percent of private insurers -- and the small difference partly reflects cost shifting. Congress periodically improves Medicare benefits, and there's a limit to how much squeezing reimbursement rates can check costs. Doctors and hospitals already complain that low payments limit services or discourage physicians from taking Medicare patients.

Even Hacker concedes that without reimbursement rates close to Medicare's, the public plan would founder. If it had to "negotiate rates directly with providers" -- do what private insurers do -- the public plan could have "a very hard time" making inroads, he writes. Hacker opposes such weakened versions of the public plan.

By contrast, a favored public plan would probably doom today's private insurance. Although some congressional proposals limit enrollment eligibility in the public plan, pressures to liberalize would be overwhelming. Why should only some under-65 Americans enjoy lower premiums? In one study that assumed widespread eligibility, the Lewin Group estimated that 103 million people -- half the number with private insurance -- would switch to the public plan. Private insurance might become a specialty product.

Many would say: Whoopee! Get rid of the sinister insurers. Bring on a single-payer system. But if that's the agenda, why not debate it directly? It's not insurers that cause high health costs; they're simply the middlemen. It's the fragmented delivery system and open-ended reimbursement. Would strict regulation of doctors, hospitals and patients under a single-payer system provide control? Or would genuine competition among health plans over price and quality work better?

That's the debate we need, but in truth, doctors, hospitals and patients don't want to be limited, whether by government or markets. Congress reflects public opinion. Fearing a real debate, we fake it.  Read More & Comment...

Comparative Effectiveness Questioned By NIH Director

10/27/2009 11:02 PM |

I wonder if Dr. Collins is laying down a (bio) marker...
www.reuters.com/article/idUSTRE59P4UD20091026
Risks to personalized medicine seen in U.S. reform

By Julie Steenhuysen

CHICAGO (Reuters) - The federal government's push to control health costs through comparative effectiveness research could threaten strides in personalized medicine, in which medicines are tailored to an individual's genetic makeup, the chief of the National Institutes of Health said on Monday.

"There is a potential collision here," Dr. Francis Collins, director of the National Institutes of Health said at a forum sponsored by the American Association for the Advancement of Science.

Collins, a genetics pioneer tapped by President Barack Obama in July to head the NIH, said studies that lump together large groups of people to test the effectiveness of treatment A versus treatment B run the risk of overlooking clusters of people for whom a drug might have a dramatic effect.

"That's going to get lost in the wash by considering everybody equivalent, which we know they are not," said Collins, who helped lead the Human Genome Project that in 2003 produced a sequence of all the DNA in people.

"The antidote to that is pretty straightforward," said Collins, saying that studies need to include genetic information that allows researchers to find such responses.
Backers of comparative effectiveness research, who include insurers and large employers, see the government-funded studies as a way to learn which treatments work best. But Collins said the studies should be well crafted.

"We need to be mindful of the goal of comparative effectiveness research and not lose all that we have gained in understanding how individuals differ and how that could be factored into better diagnostics and preventive strategies," Collins told the meeting, which was broadcast on the Internet.

COST-CUTTING POTENTIAL

There is already evidence that personalized medicine can help reduce health costs, Collins said, pointing to Genomic Health's Oncotype DX, a genetic test that can predict the recurrence of breast cancer.

"This test allows those individuals at low risk for recurrence to know they are at low risk and make a decision about whether to forgo chemotherapy, with all of its adverse consequences, based on that information," Collins said.

He said the test costs $3,500, and most women who get tested and discover they are at low risk decide to forego chemotherapy, saving an average of $2,000 per patient in additional costs from chemotherapy treatment.

"In 2009, roughly 50,000 women are going through this process, predicting we will therefore save the healthcare system $100 million this year based on the availability of this kind of personalized medical test," Collins said.

Dr. Margaret Hamburg, commissioner of the U.S. Food and Drug Administration, told the meeting that many clinical trials are structured to determine if a drug is safe and effective in a large group of patients, but the drugs often leave out the why -- why certain patients benefit while others do not.

The FDA increasingly is approving drugs with companion diagnostic tests using biomarkers -- such as specific proteins or genes -- that improve the odds that a new, high-cost biotechnology drug will work.

She said studies that look at the genetic profile of patients and its role in how drugs work could strengthen a drug's application, lending more scientific certainty about why a new drug works.

"Perhaps then we could see more new drug applications in the pipeline that are more likely to succeed," she said.

(Editing by Eric Walsh)

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Meeting With Mitch

10/27/2009 10:03 AM |

I spent an hour talking about health care reform with Indiana Governor Mitch Daniels today.  Governor Daniels -- who won his second term as the Hoosier State's CEO in 2008 with over 60 percent of the vote even as Barack Obama was carring the state --  has taken an approach to providing health care coverage that is distinctly at odds with what is being proposed in Congress in three important ways:

1.  It is not an entitlement.
2.  It provides people with control over health care spending by funding health savings accounts
3.  It both encourages and rewards healthy behavior and preventive care. 

The program is modest in scope, limited now byt the fact that the federal government will allow Medicaid funds to be used only for less than ten percent of the chronically uninsured in the state.  Part of the spending (the money put inton health savings accounts) comes from an increasein the tobacco tax.  

But it is paired with the Daniels decision to add an HSA plan for all state employees and a program to encouage Hoosiers to improve their physicial condition through better diets, more exercise, etc. 

Preliminary data shows that the state is spending less on healthcare and premiums are rising more slowly. 

More important,  before reforming or thinking about reforming an entire system, Daniels focused on:

1.  the chronically uninsured who have the hardest time paying for coverage
2.  changing the way health care isi paid for by focusing on rewarding health and giving consumers choice

In Washington just the oppostie is true.  Healthcare reform is all encompassing and is an entitlement focusing on

1.  the people who already have coverage
2.  rewarding people for not getting insurance and postponing care
3.  restricting choice

Also,  Daniels has lowered the tax rate on biomedical innovation and created incentives for patent holders. 

In Washington, taxes on innovators are going up and patent protection on innovative products will be cut in half. 


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It's a start

10/27/2009 07:34 AM |

In the heat of the healthcare reform debate, you might have missed the fact that President Obama signed an appropriations measure that provides the FDA (mostly CDER) with an additional $880.1 million in funding, of which at least $51.5 million will go to the generic drugs office -- a $10 million increase from fiscal 2009. CBER and related field activities will see a 12% budget increase to $305.2 million.

Importantly, the measure includes $18 million for the Critical Path initiative, with at least $6 million of this set aside for partnership activities.  Huzzah! Of the $6 million, $2 million will support research partnerships for the treatment or rapid diagnosis of tropical diseases, particularly tuberculosis and drug-resistant TB.  A bit of mission creep – but no complaints.

The fiscal 2010 appropriations bill also increases direct non-user fee funding to the agency by 15%, bringing the agency's total budget with user fees to $3.25 billion.

The FDA will receive about $2.35 billion in direct funding, plus $893 million in user fees. This includes $235 million in fees to fund the new tobacco products program.

Interestingly, and relative to the issue of generic drugs and bioequivalence, Congress also requires that FDA report on adverse events and seizures associated with branded and generic epilepsy medicines. According to the conference report, "Specifically, the agency should examine the pharmacokinetic properties of 'A' rated anti-epileptic drugs from different manufacturers of the same therapeutic agent," the states. The agency must submit a report by September 30th, 2010 detailing what changes, if any, should be made to the current bioequivalence testing.

Critical Path funding.  Partnership activities.  Bioeqivalence.  That’s progress.

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"Shaming" is good. Prison is better.

10/26/2009 08:46 AM |

China will launch a one-year crackdown on fake drug ads on the Internet and sales of fake drugs through postal services, according to an inter-ministerial conference on October 23. The campaign will be jointly launched by 13 ministries including the Ministry of Health, the Ministry of Industry and Information Technology and the State Food and Drug Administration (SFDA).

Health Minister Chen Zhu said Web sites, advertisement companies, postal services, medical institutions and commercial banks involved in such illegal businesses are the main targets of the crackdown.

Shao Mingli, director of the State Food and Drug Administration, said the SFDA's official Web sites will name and shame those sites advertising fake drugs to alert the public. Most recently, the administration exposed six drug producers whose advertisements contain content of over-promised efficacy and guarantee in the name of consumers.

Shaming is good -- prison terms would be even better.
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When Bipartisanship Begins with "D"

10/23/2009 01:19 PM |

When it comes to healthcare reform, bipartisanship begins with "D."

Consider this new op-ed from today's Detroit News:


PETER PITTS

Republican Congressman Bill Cassidy recently broke some news that could turn the health care debate on its head. During a radio interview, he revealed that Blue Dog Democrats have been quietly reaching out to Republicans to draft an alternative health reform bill.

This isn't surprising. After all, neither Republicans nor centrist Democrats nor the majority of Americans approve of the clumsy hodgepodge of big-government policies that make up Sen. Max Baucus' health care bill.

An alliance between Republicans and moderate Democrats could give Americans the reform package they're looking for -- one aimed at lowering costs while promoting competition and choice.

Polls show that public support for health care reform is at a new low. According to a Rasmussen poll from Sept. 28, 56 percent of Americans oppose the leading Democratic reform proposal.

They're not alone. Blue Dog Democrats -- a group of 52 moderate Democratic members of Congress -- have long been uneasy about health care reforms that give too much power to the federal government. In fact they were among the leading opponents of the government-run "public option." Although that idea seems to be off the table, there's still plenty in the Baucus legislation for these fiscally conservative Democrats to criticize.

The nonprofit health care cooperatives that the Baucus bill creates, for instance, would create many of the same problems as the public option. It's true that these co-ops wouldn't officially be part of the government, but they would benefit from federal financial backing (the Baucus bill provides $6 billion for the establishment of these co-ops) and an implied federal guarantee. Consequently, they would pose a serious threat to Americans' ability to purchase private coverage.

Since co-ops would be able to draw from a healthy supply of federal funds, they could push private insurers out of the market by offering artificially low rates. This would soon result in a health care sector with few alternatives to the federally chartered co-ops.

At the same time, the Senate bill -- which carries an $856 billion price tag -- also fails to sufficiently address the issue of cost. A recent Gallup poll showed that the No. 1 concern Americans have about health care is cost and affordability.

And a bipartisan alternative to Baucus' legislation has the potential to be the kind of practical, cost-lowering bill that American's want and America's healthcare system needs.

What would such a bill look like? It's hard to say, but one smart way to go about crafting a bipartisan bill would be to model it off existing successful health care policies -- namely, Medicare Part D.

By creating a system where private insurers could fairly compete to offer Medicare beneficiaries the best drug coverage, Part D has reduced the number of seniors without drug coverage by 17 percent, while still managing to cost about 30 percent less than originally estimated.

The program also enjoys a 92 percent satisfaction rating. This is largely because Part D provides seniors with a real choice over the kind of drug coverage they receive (the program offers over 1,800 plans).

This basic model could be used as the basis for a new bipartisan healthcare bill. Under such a program, the federal government would expand coverage to chronically uninsured -- those 8 million to 15 million Americans who can't afford private coverage but earn too much for government aid -- by creating a system of privately administered health insurance options. Customers would choose the plan most appropriate for them, and the federal government would help subsidize their premiums, depending on their need.

Such a program would keep costs down by rewarding insurance companies for providing the best coverage at the lowest price. It would also give Americans the freedom to choose from a wide array of different insurance plans.

The time is right for a real bipartisan reform to take shape.

Peter J. Pitts is president of the Center for Medicine in the Public Interest and a former Food and Drug Administration associate commissioner.

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