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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Government Run Healthcare Harms Our Health

10/22/2009 12:06 PM |

CMPI hosted a roundtable discussion with health policy leaders about the real impact of health care proposals being considered by Congress. We released new findings developed by Richard Cooper, MD a professor of medicine at U Penn challenging the claim made about every bill: that a public option or a “trigger”, health exchanges and Medicare commissions can cut “unnecessary” care, reduce spending on health by 30 percent of the total and pay for universal coverage.

Dr. Cooper's research (which can found on his blog buzcooper.com/2009/07/29/what-if-the-problem-is-poverty/ ) clearly shows that proposals to have government penalize doctors who use more services than the lowest ten percentile (or reward those who use less services), reimburse according to evidence-based guidelines which are skewed to the less is best bias inherent in comparative effectiveness research, cut back payments to doctors in Medicaid and Medicare based on this mindset, limit the introduction of new technologies where government payment predominates, and envision increasing the number of Americans receiving care under this framework will mean cutting back drastically on access to medical treatment for poor people in urban areas.

Our panel of experts, moderated by CMPI senior fellow and former Congressman Mike Ferguson observed that central features of the current bills in Congress will guarantee that health care gets worse for minorities and the chronically ill, not better.

Michael Cannon, who runs health policy studies at Cato Institute (www.cato.org/people/michael-cannon ) noted that because Medicare and Medicaid are already the largest single source of payment, expanding the model will make it even harder to shift resources or change thinking in ways to focus on illness or disease prevention. The political culture will simply reorganize around the larger bureaucracy.

Joe Antos, the Wilson H. Taylor Scholar in Health Care and Retirement Policy at the American Enterprise Institute (www.aei.org/antos) pointed out that health care is a series of choices about care, cost, coverage and behavior. The issue is who should make these choices. The current proposals are hell-bent in centralizing such important decisions into the hands of a few government planners. Choices made by many to allocate resources thereby become rationing.

Jim Frogue , who is deputy director of Newt Gingrich's Center for Health Transformation (www.healthtransformation.net/cs/jim_frogue) emphasized that behavior is the key to health status for most chronic illnesses. Reforms that fail to focus on health improvement in a signficant way, or fail to free people to pursue prevention will make matters worse. While best practices are not one size fits all, Frogue noted that prevention approaches can be shared, adapted and refined for specific populations.

Finally, Gary Puckrein, President of the National Minority Quality Forum noted that advances in medical technology explain a considerable amount of the increase in life expectancy and survival over the last 50 years. The forum www.nmqf.org has identified by zip code where the greatest incidence of the most serious and costly chronic disease exists. It has tracked to the patient level who will cost the most in terms of Medicare expenditures and why. The failure to prevent diabetes explains much of the growing cost of Medicare and it can be traced to specific urban areas, areas that will see money cut because it is defined as "wasteful" when it could be transformed into more effective forms of care.

The battle of health care then is not "yes" or "no" but "how." Medical innovation is and should continue to be an American growth industry and a source of productivity. The current approach to reform undermines and discourages transformation, drives up cost and slows the development of the next generation of technologies.

More importantly, the mass of regulation assures that the health care equivalent of a Bill Gates or Eric Schmidt will not emerge to lead and transform a critical and competitive American industry.    Read More & Comment...

Emissions Impossible

10/22/2009 08:48 AM |

Ad Age reports:

 U.S. Senator Al Franken (D-Minn.), along with co-sponsors Sens. Sherrod Brown (D-Ohio) and Sheldon Whitehouse (D-R.I.), have introduced legislation (S. 1763) to disallow the federal tax deduction for all advertising and marketing expenses for prescription drugs. There are rumblings that the senators would like to have the proposal added to the health-care reform legislation, and the possibility exists that they may offer it as an amendment when the proposed bill is considered by the full Senate.

Former Food and Drug Administration associate commissioner Peter Pitts, now the president of the Center for Medicine in the Public Interest, said the proposed legislation to cut the ad tax deductibility endangers more than just the health-care reform bill.

"What this endangers is the public health, as every survey -- including those done by the FDA -- show that DTC advertising, beyond helping to sell product, actually increases the health literacy of the American health consumer," he said. "Such a move is actually an anti-health reform amendment and is nothing more than grandstanding by a long-time opponent of the pharmaceutical industry [Mr. Brown] and a 'Saturday Night Live' alum [Mr. Franken]. Painting pharmaceutical marketing as an 'enemy' of health reform is like saying automotive advertising is the enemy of emissions control."

The full Ad Age article can be found here:

 http://adage.com/article?article_id=139826

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Katy Bar(code) the Door

10/21/2009 08:36 AM |

SCRIP World Pharmaceutical News reports that, “The European pharmaceutical industry association, EFPIA, today launched its anti-counterfeiting pilot project in Sweden, raising concerns among parallel traders that should it be rolled out across the EU, the scheme's central database may be misused by manufacturers to curb sales to certain wholesalers.”) This follows up on the commission's legislative proposal for some sort of authentication process, but which stopped short of recommending an actual type.

The pilot scheme involves 25 pharmacies in the Stockholm area. Pharmacists will be scanning about 110,000 pharmaceutical packs that have a special two-dimensional barcode (similar to those found on airline boarding passes) using a scanning device at the point of dispensing.

The scanned product would be checked against the manufacturer's records in a central database to verify whether it is genuine, as the product would have a unique serial number. The data matrix would be enough to individually code each medicine pack with information including a product code, batch number, expiry date and a unique serial number.

The system has proven to be a cheaper and easier solution to implement than other authentication schemes such as track and trace and RFID tagging, believes EFPIA. It also offers advantages such as reducing dispensing errors and reimbursement fraud.

Heinz Kobelt, secretary general of the European parallel traders association, the EAEPC, is concerned about who is "master of the data" in the central database. "If pharmaceutical manufacturers get free access to the data, they can use it against parallel traders. We need an independent agency to run the central database."

Colin Mackay, EFPIA's spokesperson, told Scrip that it was uncertain who would fund the scheme if it were rolled out across Europe, but financers should include all stakeholders, including the pharmaceutical industry, wholesalers, pharmacists, parallel traders and member states.

The EFPIA system is being piloted in collaboration with the European wholesaler trade association, GIRP, and local Swedish full-line wholesalers Tamro and Kronans Droghandel. EFPIA has said that accredited full-line wholesalers would be able to access the database to check the status of the product at any time.

The European Parliament's Committee on the Environment, Public Health and Food Safety is expected to issue a report on the Commission's counterfeiting proposals next month. EFPIA plans to issue the results of the completed pilot early next year.

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Total Ellipse of the Sum

10/20/2009 10:42 AM |

The Senate Finance bill is over 1500 pages long.  But when it comes to the infamous “Doc Fix” (and its nearly 10 year $250 billion price tag), there’s only a one-year patch – with the cost offset by taxes and reduced spending elsewhere.

What about the other nine years?

That, it seems, is the purview of S.1776 and, according to the New York Times, “Congressional Democrats have no plans to offset the cost of S. 1776, which is why they are eager to keep it separate from the broader health care legislation and avoid breaking the president’s promise.”

That promise again, “I will not sign a plan that adds one dime to our deficits — either now or in the future. Period.”

Well, it seems that many in Congress are looking at the “period” and seeing an ellipse.

The Times continues, “Congressional Democrats insist that fixing the doctor payment formula should not count toward the cost of the big health care legislation, because it is a problem they inherited.”

Unlike the problem of the uninsured?  Unlike the problem of preexisting conditions?  Unlike the problem of the donut hole?  Unlike the problem of (FILL IN THE BLANK)?

Sounds like a total ellipse of the sum.

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Outrage - Government Attempts Takeover of Cable Industry!

10/19/2009 05:09 PM |

Please help CMPI create a viral buzz with our new web ad. Share this video with your social networks and email lists.

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Galen Poll Cuts To The Heart of Healthcare Debate

10/19/2009 02:02 PM |

Finally, a poll that asks Americans specific questions about the actual details of the proposal squirming through Congress....

Galen Institute Releases Poll Showing Overwhelming Opposition to the Individual Mandate and Other Key Components of Congressional Health Reform Proposals

Seventy-one Percent Are Concerned Their Health Insurance Will
Change if Congress Passes Health Reform Legislation

For more information, please contact:
Jeff Lungren, Communications Director
(703) 299-9207 or jeff@galen.org

ALEXANDRIA, VA. OCTOBER 19, 2009 – The Galen Institute today released new survey results showing overwhelming opposition to the individual mandate and other key components of health reform legislation Congress is considering.

“These findings illustrate strong opposition to fundamental aspects of the bills moving through Congress,” said Galen Institute President Grace-Marie Turner. “People don’t want to be forced to buy insurance they can’t afford or that might not fit their needs, yet the proposals would slap a tax on them if they don’t. And people overwhelmingly oppose reducing seniors’ health benefits or raising taxes on the working and middle class in order to expand coverage to some of the uninsured, yet many in Congress continue to push exactly that.”

“What the public does favor is a targeted approach to solving problems in our health sector, but not a complete Washington-style overhaul of one-sixth of our economy. Washington’s failure to listen is causing great apprehension and concern among the public,” added Turner.

The nationwide random survey of 510 adults was conducted October 8-11, 2009 and has a +/- 4.34 margin of error. International Communications Research (ICR), a non-partisan research firm based in Pennsylvania, conducted the survey.

More Than Seven in Ten Oppose the Individual Mandate

Seventy-one percent of those surveyed said they would oppose “a new law saying that everyone either would have to obtain private or public health insurance approved by the government or pay a tax of $750 or more every year.” Only 21 percent said they would support the law. More than half (54 percent) of all respondents indicate a “strong” opposition to the individual mandate, including 58 percent of those 45-54 years of age and 58 percent of those 55 years and older.

More Than Two-Thirds Oppose Reducing Seniors’ Health Benefits to Pay for Covering the Uninsured

More than two-thirds (68 percent) oppose reducing “some health insurance benefits for senior citizens in order to expand health insurance for some people who are uninsured,” while 28 percent support the idea. Opposition is spread across political party lines as 86 percent of Republicans, 66 percent of Independents, and 59 percent of Democrats oppose this idea.

Opposition to Raising Taxes on the Working and Middle Class to Cover the Uninsured

Fifty-eight percent disagree, most of them “strongly” (44 percent), with the following statement: “I would support an increase in taxes on the working and middle class if it would help provide health insurance to more Americans.” Only 39 percent support the position.

Seventy-one Percent Are Concerned Current Health Insurance Will Change if Congress Passes Health Reform

Seventy-one percent said they were concerned that their current health insurance would change if Congress passes health reform legislation. One-quarter (25 percent) said they were not concerned. Groups with the highest level of concern include: people 55 years and older (84 percent), those aged 45-54 (80 percent), Republicans (82 percent), and Independents (78 percent). Almost half (47 percent) of all respondents indicate they are “very concerned.” Sixty-two percent of people aged 55 years and older are “very concerned,” along with 61 percent of Republicans, 63 percent of those in the South, and 54 percent of Independents.

Support for a Targeted Approach to Addressing Health Care

Forty-nine percent support, “A targeted approach that addresses a few problems at a time.” Forty-one percent support, “A comprehensive approach that makes significant changes to our current health care system.”

_________________________________

Here are Details of the Survey’s Results

Question: Let's say that Congress passed a new law saying that everyone either would have to obtain private or public health insurance approved by the government or pay a tax of $750 or more every year. Would you support or oppose this law?

STRONGLY SUPPORT 13%
SOMEWHAT SUPPORT 8%
SOMEWHAT OPPOSE 17%
STRONGLY OPPOSE 54%
DON’T KNOW/REFUSED 8%


Question: Which of the following approaches to health care reform do you favor?

A comprehensive approach that
makes significant changes to our 41%
current health care system?
A targeted approach that
addresses a few problems at a time? 49%
NEITHER 4%
DON’T KNOW 5%

Question: Do you agree or disagree with the following statement? "I would support an increase in taxes on the working and middle class if it would help provide health insurance to more Americans."

STRONGLY AGREE 18%
SOMEWHAT AGREE 20%
SOMEWHAT DISAGREE 14%
STRONGLY DISAGREE 44%
DON’T KNOW/REFUSED 4%

Question: How concerned are you that your current health insurance will change if Congress passes health reform legislation? Are you ...?

VERY CONCERNED 47%
SOMEWHAT CONCERNED 24%
NOT VERY CONCERNED 9%
NOT CONCERNED AT ALL 17%
NOT APPLICABLE/ I 3%
CURRENTLY DO NOT HAVE
HEALTH INSURANCE
DON’T KNOW 1%

Question: Let's say Congress proposed a bill that would reduce some health insurance benefits for senior citizens in order to provide health insurance for some people who are uninsured. Would you support or oppose this bill?

STRONGLY SUPPORT 13%
SOMEWHAT SUPPORT 15%
SOMEWHAT OPPOSE 20%
STRONGLY OPPOSE 48%
DON’T KNOW 4%
###

 

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Warts and All

10/19/2009 08:40 AM |

On September 29^th, the New York Times reported:

Former Drug Executive Convicted of Wire Fraud

In a verdict that could strike fear into pharmaceutical industry executive suites, the former head of a drug company was convicted of wire fraud Tuesday for issuing what federal prosecutors called a misleading press release that contributed to off-label sales of his company’s drug.

(Full story here: http://www.nytimes.com/2009/09/30/business/30drug.html)

There are rules that need to be followed and there are consequences for those who play fast and loose with them.

Except, it seems, if you are the rule-maker.

Here’s an FDA announcement that appeared Friday (October 16^th):

FDA Approves New Indication for Gardasil to Prevent Genital Warts in Men and Boys

The U.S. Food and Drug Administration today approved use of the vaccine Gardasil for the prevention of genital warts (condyloma acuminata) due to human papillomavirus (HPV) types 6 and 11 in boys and men, ages 9 through 26.

(Full FDA release here: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm187003.htm)

Wonderful public health news and certainly worth promoting. And kudos to the FDA for using a regulatory action to discuss an important public health issue.

The interesting issue is how the release ends:

“Gardasil product information: www.fda.gov/cber/products/gardasil.htm”

That link doesn’t bring you directly to the package insert, but rather to a page where you can access the package insert. 

Would a pharmaceutical company be permitted to forward such an FDA announcement along to others without more detailed risk information?  What about posting the FDA announcement to a commercial website?  What about handing it out to physicians?

In 2002, when I was the FDA's associate commissioner for external relations, Dr. Janet Woodcock (then, as now, CDER Director) came in to my office and she was not smiling. She waved a draft of a new drug approval press release at me and asked, "How is anybody supposed to understand this? It's written for scientists!"

I felt her pain. My answer to Dr. Woodcock was that the press office had written a much more consumer-friendly document, but that the release had, quite literally, been doctored when sent to the Center for Drug Evaluation and Research for review. Rather than focusing on the important public health message intrinsic in the new drug approval, the career science staff insisted on putting in more science. "Well," she said, "that's not going to happen anymore." And that was the beginning of a beautiful relationship.

What that story demonstrates—and why I never tire of retelling it—is that communications at the FDA is a perfect example of the maxim, "It's not what we say that matters—it's what our target audience remembers." All the science in the world—precise and important as it may be—is not going to help the average consumer understand why a new drug is important, why it was approved, or even what it does.

So, this isn’t about FDA needing to add more risk information – their release speaks in plain English to the general population.  Well done.  The question is, shouldn’t pharmaceutical companies be allowed to do the same?  Isn’t a clear message in the best interests of the public health? What’s required is a more titrated approach to communications that -- like DTC TV guidance -- provides a clear pathway for achieving compliance while respecting the inherent space/time limitations of any given medium. 

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