CCHIT Happens

07/17/2008 03:35 PM |

From the pen of Secretary of Health and Human Services Mike Leavitt:

Commission’s rigorous testing helps ensure interoperability of technology

As Congress takes up the subject of health information technology, it must take great care to enable accelerated progress rather than sending the process back to the starting line.

My vision of health information technology in the United States is a world where medical information can be privacy-protected and managed in a way that produces better quality, lower costs, fewer medical mistakes and less hassle for everybody. Building such a system requires that clinics, hospitals, pharmacies, labs and patients have systems that speak the same language — that are “interoperable.”

Getting health information systems in various parts of the healthcare system to work together requires the adoption of common technical standards. I’ve often compared the problem to the building of railroads. Before the railroads of the East, West, North and South could be interoperable, they all had to agree on one standard track size. A similar process is required with health IT, except that the degree of difficulty is much harder than just agreeing on a track size.

There are more than 200 developers of electronic medical record systems in the United States.

Until three years ago, there was no process for harmonizing and coordinating the standards they used. To remedy this problem, we formed the American Health Information Community (AHIC). It has succeeded, and as time passes we are seeing an accelerating stream of solid and widely accepted health IT standards emerge.

People who buy systems need to know they are making an investment that will connect them with the rest of the medical world. Today, they can buy with confidence.

The Certification Commission for Healthcare Information Technology gives systems a rigorous testing to demonstrate interoperability. Those systems that pass the test are given CCHIT certification. When doctors buy systems with that seal, they know that they are on a pathway to interoperability. This has given many doctors the confidence to buy who were waiting before.

We have seen more progress toward interoperability in the past three years than in the previous two decades. This is because government agencies, the medical family, the insurance industry and the health IT sector are all working together collaboratively.  This type of collaboration is hard and requires great effort, but it is working, and its momentum is increasing.

As Congress begins to write a health IT bill, it is critical that it be crafted in a way that does not interrupt this success by imposing government controls. Government has to be at the table as a full participant, but if the bill prescribes the way these standards are to be set, or puts in place a politically controlled process that picks winners and losers, it will devastate a healthy but fragile process and lose three years of maturity and momentum.

I would offer three principles to members of Congress in dealing with legislation:

First, let’s protect the flexibility of those who are working to invent new tools, and let’s not undermine the work on AHIC that is already underway. Writing legislation to bias the process in one direction or another will constrict innovation and slow the process.

Second, let’s not try to solve all the privacy challenges of the 21st century in a health IT bill. We have to be careful to avoid penalizing early adoption.

Third, let’s respect the need for legitimate healthcare communications. We have to find the balance here. It is in the patient’s best interest for doctors and the patient to have information.

The most important thing government can do is adopt the standards ourselves. The adoption of standards by Medicare, the Veterans Administration, the Department of Defense, and Indian Health, is critical.

We’re making progress on health information technology. Let’s make sure that any legislation accelerates the progress already under way, rather than chilling it with requirements that the government dictate one-size-fits-all answers.

  Read More & Comment...

Culture Vulture

07/17/2008 01:23 PM |

Now here's a healthcare story that deserves to be on Page One. 

But since it's not about coffee mugs or pens, or adverse events -- it's not.

Hepatitis C, investigators report that they have developed the first tissue culture of regular human liver cells that can imitate infections with the hepatitis C virus (HCV).
 

"This is the first efficient and consistent model system for HCV to be developed," Martina Buck, assistant professor of medicine at the University of California, San Diego, School of Medicine, who developed the culture, said in a university news release. "There is a need for new treatments, and for development of a possible vaccine for HCV. Now we have a model system to support work by investigators in this area."

Some 170 million people worldwide are infected with hepatitis C, which affects the liver. In the United States alone, some 10,000 people die from cirrhosis of the liver, and thousands more die from liver cancer associated with infection.

The virus is usually transmitted by sharing intravenous drug needles and through sexual contact.

Right now, there is no animal model to test different therapies, according to background information in a paper published in the July 16 issue of PLoS ONE.

The therapy can also cause severe flu-like symptoms.

Researchers have so far been hampered in their efforts to understand HCV, because it hasn't been possible to infect normal human liver cells in a laboratory setting.

The new culture allows scientists to directly infect cells with virus from the blood of HCV-infected patients.

  Read More & Comment...

Disadvantage Medicare

07/17/2008 01:15 PM |

There is a lot of cheering about the fact that payments to HMOs under the Medicare Advantage program were cut to temporarily stave off an 10 percent cut in Medicare fees to doctors.

A few things:

First, the cut was inflated by those want to kill MA because it was a departure from the government run Medicare program. By pitting doctors against the HMOs it achieved what pitting kids against HMOs didn't do in expanding SCHIP since, as most people have forgotten, the MA payments were going to fund health insurance for kids. So much for the Hobbesian choice.

Second, these cuts will hurt seniors directly and soon. HMOs had to use the extra payments to bring in the sicker and more chronically ill patients and get them healthier...which is what health care is supposed to do. They did so with lower premiums, more care and better disease management. As Mark McClellan noted in Congressional testimony;

Overall, compared to fee-for-service Medicare, beneficiaries in Medicare Advantage plans have much lower out-of-pocket costs; they receive significantly more preventive benefits, drug coverage, and services to help them better manage their chronic diseases; they have very high satisfaction rates; and in most cases, their overall care costs (Medicare plus beneficiary) are lower.

For example, Medicare Advantage beneficiaries

For example, Medicare Advantage beneficiaries receive preventive services like mammograms, colorectal cancer screening, prostate screening, and immunizations at significantly higher rates than beneficiaries in traditional fee-for-service (FFS) Medicare.

In addition, compared to other Medicare beneficiaries without supplemental “Medigap” coverage, MA beneficiaries are only one-third as likely (6 percent versus 17 percent) to report delaying the use of needed care due to cost.1

MA beneficiaries also receive higher quality of care in many areas; for example, a study in the Journal of the American Medical Association found that beneficiaries in MA plans received higher quality of care than beneficiaries in traditional FFS Medicare in five of seven HEDIS quality measures studied.2 Quality is reflected in overall high beneficiary satisfaction rates with their coverage: Consumer Assessment of Health Plans Surveys (CAHPS) generally rate MA plans highest among a range of types of health plans.3

These quality of care results are the consequence of how most MA plans provide coverage. Plans receive a single, risk-adjusted payment from Medicare, and they compete to attract and keep beneficiaries by using this subsidy to provide the most attractive benefits at the lowest overall cost. In contrast, in traditional FFS Medicare, benefits are determined by statute and cannot easily include many innovative approaches to benefit design, provider payment, care coordination services, and personalized support for beneficiaries. Through MA plans, beneficiaries across the country have access to plans with lower or zero copays for preventive services; they have widespread acces to wellness programs; they have access to dental and vision services that not only reduce costs but also help beneficiaries live better and improve their overall health.

Importantly, MA plans are also providing drug coverage that is more extensive and much less costly than in traditional FFS Medicare. This difference in generosity and cost, which increased between 2006 and 2007 and may continue to increase in the future, is likely the result of several factors. First, most MA plans can manage the use of prescription drugs more effectively, as part of their efforts to support the overall coordination of care for a patient’s health. Second, higher compliance with drugs has been shown to reduce other health care costs,4 and because MA plans have incentives to keep overall costs down that do not exist in traditional FFS, they can capture the savings in hospital, physician, and other costs from the greater compliance that comes with more comprehensive drug coverage. Again, this is a more efficient approach to health care coverage.

Finally, most MA plans provide much more support for patients with chronic diseases than is available in traditional FFS Medicare. This is critically important, since the vast majority of costs in Medicare – and most of the cost growth in Medicare – relates to treating the complications of a limited number of serious chronic diseases. Our health care system has huge and persisting quality gaps in the prevention and treatment of chronic diseases. There is no population in this country that needs such personalized services to improve coordination and prevent complications from chronic diseases more than Medicare beneficiaries.

All of these features – better preventive care, lower out-of-pocket costs, better drug coverage, better support for quality care for chronic diseases – are signs of more efficient health care. Not surprisingly, they add up to very large savings for beneficiaries – on average, out-of-pocket costs are $86 a month less in MA, compared to traditional FFS. Medicare with Medigap (counting beneficiary premiums) or no supplemental coverage. That’s more than $1000 a year in savings. This is why a recent analysis by Adam Atherly and Ken Thorpe of Emory University concluded that even though MA payments increase Medicare costs, “the size of the increase in costs will be less than the value of the supplemental benefits provided to beneficiaries” – that is, overall costs to beneficiaries and the Federal government are lower in the MA plans.5 (Similarly, according to MedPAC testimony before the Ways and Means Committee in May, average bids across all Medicare Advantage plans for Part A and B services are lower than the average cost of traditional FFS Medicare6 - and when Part D benefits are included, the cost differences are larger.)

Now all this value in health care will dry up. Republicans -- at least those that voted against robbing seniors of better care to finance a short term extortion of doctors who are already being screwed by Medicare -- should make this a campaign issue.

Do we really want our health care decisions to be run from Washington?  Read More & Comment...

Where's Eliot Spitzer when you need him?

07/16/2008 10:46 AM |

At least they’re not giving doctors any pens or coffee mugs.

From today's edition of the NY Sun:

Insurers Pay Doctors To Push Generic Drugs

Some Physicians Resist Incentives While Taking Payments From Prescription Firms
By E.B. SOLOMONT,

Two New York health insurance companies are rewarding doctors with cash incentives for prescribing generic drugs.

The companies, Excellus Blue Cross Blue Shield of Rochester, NY and Independent Health, based in Buffalo, are offering higher compensation to doctors who increase their rates of prescribing generics instead of more expensive brand-name medications. The companies say the programs were designed to control the escalating cost of pharmaceuticals and to pass on savings to the patients.

Doctors say that generics sometimes can be safely substituted for brand-name drugs. But some of them also are skeptical of the payments from insurers, saying they could raise ethical questions and even jeopardize the safety of some patients.
"By offering incentives to prescribe generics, there's at least the appearance for an ethical conflict, steering toward the cheaper medication," an Albany cardiologist, Dr. Mikhail Torosoff, said. "That's upsetting."

Insurers defend the practice as a way to rein in costs.

"What we're focusing on here is how do we make health insurance more affordable, and one way of doing that is to promote more cost-effective health care treatments," the senior vice president of the New York Health Plan Association, Leslie Moran, said.

She dismissed the notion that physicians are being coerced. "Everyone likes to talk about the availability and accessibility of health care," she said, "but you can't expand access if its not affordable. A key component of affordability are costs like prescription costs."

Similar programs elsewhere in the country have come under fire. In Michigan, lawmakers and physician groups opposed an incentive program launched by a subsidiary of Blue Cross Blue Shield of Michigan, Blue Care Network, which ran a three-month program that paid doctors $100 for each patient who switched to a generic cholesterol-lowering medication from a brand-name drug.

In response to the backlash, the American Medical Association posted a position statement on its Web site that reads: "A physician accepting payment from an insurer in exchange for moving a patient from a brand name to a generic drug could potentially face both criminal and civil liability exposure under the federal antikickback statute."

Generic drugs that are approved by the Food and Drug Administration must be the "bioequivalent" to their brand-name counterparts, meaning their active ingredients must be the same, drug experts said.

But some doctors said they are wary about switching the drug regimens of patients who are doing well. Prescribing a different drug within the same class could harm a patient, some said.

"The more serious the drug, the more concerned I am about forced substitution," an associate professor at NYU School of Medicine, Dr. Marc Siegel, said.

In New York, the incentive programs offer doctors increased reimbursement if they change their prescribing habits. Under Independent Health's program, doctors who increase the rate at which they prescribe generics receive a cash reward based on their patient base. A physician who increases their rate to 70% from 40%, for example, would receive fifty cents each month for each Independent Health member whom they treat.

Under the Excellus plan, doctors who increase their ratio of generic drug prescriptions to brand-name ones by 5% receive higher reimbursement for patient office visits. The company declined to provide further details on how much doctors are paid, citing proprietary reasons, but officials said the overall goal of the program is to encourage patients and physicians to consider generics.

Officials from Independent Health said their program seeks to educate patients, but they are also rewarding doctors for doing the "extra work" associated with discussing generics with their patients. "Like it or not, physicians are in a business," the company's vice president of pharmacy services, John Rodgers, said.

Other health insurance companies denied plans to launch similar programs. But doctors said a number of companies issue "report cards" that include a tally of the prescriptions that physicians write.

At least one company, Cigna, said it issues quarterly reports to physicians as part of a "Save with Generics" program, which seeks to promote the use of generics by informing patients and doctors how much money they could have saved by avoiding costly brand-name drugs.

"The only purpose is to inform physicians of opportunities to help their patients save money on their prescription medications," the director of public relations for Cigna, Lindsay Shearer, wrote in an e-mail message.

Physicians said the letters and faxes they routinely receive from insurers, which inform them when they could have saved their patients money, amount to unwanted pressure to choose generics. Other tactics used by insurance companies to reduce costs include requiring patients to obtain prior authorization for more expensive drugs, drawing up "preferred" lists of medications, and placing medicines in tiers based on cost and requiring patients to pay more for certain drugs.

"This clearly puts the burden on the doctors to 'fall in line' with the prescribing wishes of the companies," a Manhattan cardiologist, Dr. Adam Deutsch, said.

Dr. Deutsch said most of the time there is no medical reason why a generic cannot be substituted for a brand-name drug. "In all honesty, there's like seven cholesterol drugs on the market. Does it matter? No, it doesn't," he said. "The key is interference. Why is this multi-billion dollar company writing me a letter about my relationship with my patient? To me, it's an ethical issue, not a clinical one."

In recent years, doctors have been scrutinized for accepting drug samples and free lunches from pharmaceutical companies. Both practices are common, and doctors interviewed for this article said they have accepted such gifts. But they distinguished accepting drug samples and lunches from cash incentives by describing the cash incentives as bribes.

Dr. Torosoff, the Albany cardiologist, said he has been paid to speak at events sponsored by drug companies. He declined to say how much he was compensated, but he said the practice is different from accepting a cash incentive from an insurance company because as a lecturer he is performing a service and because he only lectures on FDA-approved drugs and their intended uses.

Dr. Torosoff said pharmaceutical companies have also funded research at the hospital where he works, Albany Medical Center, but he defended such grants by saying he did not personally benefit from them. Regarding the free lunches he has accepted from drug companies in the past, he described the meals as an "advertising" opportunity for pharmaceutical companies. "It's laughable to think I will prescribe something that is harmful to my patients because I got a five-dollar lunch," he said.

Officials from the state's medical society said their position is clear regarding financial incentives given to doctors who prescribe generics: A doctor's primary focus should be on their patient's welfare. "I don't criticize the insurance companies for wanting to contain costs, that's a laudable goal," the executive vice president of the Medical Society of the State of New York, Rick Abrams, said. But he said when conversion is done solely for purposes of cost and not quality, "then we have a severe problem with a program like that."

At least one New York lawmaker, a state senator of the Bronx, Jeff Klein, is proposing legislation that would require all medically necessary prescriptions to be covered by insurance companies. In May, Mr. Klein's office published a report that identified widespread restrictions placed on drug coverage by 19 health maintenance organizations in New York. Of the drugs surveyed, Lipitor, which is used to lower cholesterol, and Singulair, a medication for asthmatics, were the most restricted. Eight companies restricted Lipitor's use, and 11 companies limited Singulair's use.

Mr. Klein said restrictions do not benefit consumers, particularly those who take "single-source" medications, or drugs without a generic equivalent. "They're making it difficult for people to get the drugs they need," Mr. Klein said.  Read More & Comment...

Drat those unintended consequences!

07/15/2008 11:56 AM |

“Importation” would likely average out the cost of medicines by lowering U.S. prices and raising them in other countries. PhRMA?  No, McCain campaign advisor Gail Wilensky.

After all, “importation” is, ultimately, the importation of foreign price controls.

Oh yes – and then there are all of those pesty safety questions.

Drat those unintended consequences. So inconvenient for political rhetoric.   Read More & Comment...

DeBakey Hailed As Greatest Surgeon Ever As Grassley Launches Investigation Into Deceased Doctor's Ties to Device Industry

07/15/2008 05:25 AM |

Dr Michael DeBakey, the world famous heart surgeon who, according to the AP, "pioneered such now-common procedures as bypass surgery and invented a host of devices to help heart patients" died last week at age 99, was hailed by most as a pioneer for his 70 years of work and innovation.  At the same time, Senator Charles Grassley has launched an investigation into what, according to a report by Gardiner Harris of the NYT, might possibly be unreported consulting fees of millions of dollars that DeBakey received over that same time span from various medical device companies as well as contributions from such companies to the Michael DeBakey Heart Institute.

According to a letter released by Senator Grassley's office:  "I have it on good authority that money from device companies can corrupt research and actually turn devices and  procedures such a bypass surgery ineffective.  There are serious questions as to whether or not Dr. DeBakey's devices were actually needed and whether bypass surgery is truly safe and effective.  Indeed, there are questions as to whether Dr. DeBakey actually existed at all..."

As with other Gardiner Harris articles, the article on Dr. DeBakey consists of:

1. A leaked letter from Senator Grassley's office that is quoted uncritically
2.  Linked in ad hominem fashion to other "scandals" such as a device manufacturer giving hospitals grants which in no way are related to Dr. DeBakey but Harris wrote about and since he is too lazy to do real reporting he recycles the material
3.  Quotes from critics who never met Dr. DeBakey but hate industry in general and are on Harris' speed dial.

Grassley's office has issued a subpoena to Dr. DeBakey requesting he provide information relating to "all fees received from all device companies during periods specified by this office."  When reminded that Dr. DeBakey was deceased, Senator Grassley remarked: "That in itself is no excuse for evading the wrath and reach of my office.  Does anyone know if DeBakey was actually a ministry?    Read More & Comment...

It took me 4 days to hitchhike from Saginaw

07/14/2008 08:03 PM |

This election year, many will call for "universal health care" promising that it's a simple solution to problems we face. But the facts prove otherwise.

Those who advocate a government-run health system for the United States often point to the British National Health Service and the Canadian health system as models of state-financed -- and high-quality -- health care. Just look at the statistics and international rankings from groups such as the World Health Organization, they say.

Don't be fooled. As the saying goes, statistics are like a bathing suit. What they show you is interesting, but what they conceal is essential.

And what does the World Health Organization's data conceal? That the United Kingdom and Canadian health care systems focus more on saving money than on caring for patients. As a result, citizens of these countries experience long wait times, a lack of access to certain treatments and, in many instances, substandard medical care.

For example, a typical Canadian seeking surgical or other therapeutic treatment had to wait 18.3 weeks in 2007 -- an all-time high. Approximately 875,000 Canadians are currently on waiting lists for medical treatment.

Many Canadians can't even get routine care. Of those who sought routine or ongoing care in 2005, one in six had trouble even getting into a doctor's office for a routine procedure or check-up.

It's no better across the Atlantic. Patients with serious illnesses such as cancer face much longer odds of survival in government-run health care systems. In the United Kingdom, the five-year survival rate for patients diagnosed with breast cancer early on is 78 percent -- compared to 98 percent for similar patients in the U.S.

It's easy to understand why the public doesn't know the truth about universal health care. Politicians and polemicists have clouded the issue, deliberately ignoring the major problems with government-run health care and promising that "universal health care" will be "free."

But when it comes to health care, there ain't no such thing as a free lunch.

Here’s the rest of the story from a newspaper serving a part of the country that’s going to get a lot of attention in the weeks leading up to November 4^th -- The Saginaw News:

Read article

Our national conversation about health care has to advance beyond vague concepts and convenient political rhetoric. Government guarantees of universal care may sound appealing, but as universal systems elsewhere have shown, those guarantees are little more than hot air.

  Read More & Comment...

Good Intentions and Unintended Consequences

07/13/2008 10:30 PM |

Officials with California's state Board of Pharmacy recently announced that they're pushing back the implementation of a controversial law to create an electronic chain of custody for pharmaceuticals. This is welcome news, as the law would have created a logistical and financial nightmare – and significantly raised the price of medicines in California.

Passed in 2004, the law's aim was noble – beat back the rising tide of counterfeit drugs by establishing a statewide system for tracking prescription drug shipments from point-of-production to point-of-sale.

The law's problem, however, was that it would have imposed back-breaking costs on pharmaceutical manufacturers and dramatically inflated drug prices for consumers – while doing little to undermine counterfeiters. That's why, rather than just delay the law, officials should scrap it entirely.

A universal tracking requirement is a shotgun-style solution to a problem better suited for a precision, SWAT-team approach.

Constructing and maintaining tracking technology is expensive. Under the law, every pharmacy in California would have to install equipment costing $10,000 to $40,000 – with no help from the state. Every other business along the distribution chain (drugmakers, hospitals, shipping companies, etc.) would also have to install this technology.

Those increased production costs mean higher drug prices for consumers, and less money for research and development and other promising technological investments like electronic medical records.

It's also unwise for state officials to dictate what kind of tracking technology companies should use. Counterfeiters are devising increasingly sophisticated ways to copy and sell brand-name pharmaceuticals. Drug carriers need to be given the freedom to respond in kind. This law locks them into a technology that could soon be antiquated.

Here's a real solution: Increase the criminal penalties for counterfeiting. As is, punishments aren't proportional to the threat posed to public health. Today, counterfeiting a prescription drug label is punishable with a decade of jail time. Counterfeiting the drug itself? A maximum of three years. That's just not acceptable.

Here’s the rest of the story as it appeared in the Orange County Register:

Orange County Register Op-Ed

Tracking legislation should come from the federal level – a single, uniform system administered by the FDA. A mishmash of state laws is wildly inefficient and will only create weak links in our national chain of custody that will certainly be exploited by criminals who don't think twice before putting counterfeit drugs into Americans' medicine chests.  Read More & Comment...

Grassley's Obsessions

07/13/2008 09:05 PM |

Here’s Senator Chuck Grassley on the APA’s use of money for medical symposia and other activities….

"I have come to understand that money from the pharmaceutical industry can shape the practices of nonprofit organizations that purport to be independent in their viewpoints and actions," Mr. Grassley said.

That’s rich, coming from someone who said: "everything about ethanol is good, good, good."

I have come to understand that money from the soybean and biofuels industry can shape the practices of a Senator from Iowa that purports to be independent in his viewspoints and actions and who makes a career implying that money alone is the sole factor in forming judgments.

Or how about taking responsibility for creating and propping up this monster called ethanol?

“According to the Global Subsidies Initiative of the International Institute for Sustainable Development, ethanol tax credits and incentives will cost U.S. tax payers between $6.3 and 8.7 billion dollars annually between 2006 and 2012. Additionally, according to a study conducted by the Center for Agricultural and Rural Development (CARD) at Iowa State University, the price of ethanol is being held artificially high by import tariffs imposed on foreign producers of ethanol. According to one of the authors, “Removing trade distortions would decrease the price for U.S. ethanol, while the world price would increase, as U.S. demand — and ethanol imports — would increase.” The drop in domestic ethanol prices could be as much as 18%.”

Now, I might be mistaken. But for a guy who is stressed about governmenet officials being too cozy with industry Grassley might want to start with himself. Here’s the record:

“Agribusiness giant Archer Daniels Midland Co. (ADM), the single largest beneficiary of a controversial federal ethanol tax subsidy, contributed more than $3 million in unregulated "soft money" to Republican and Democratic national party committees during the past 10 years, according to a study by Common Cause.

ADM gave direct political action committee contributions to congressional candidates: $700,170 to Democrats and $529,276 to Republicans from Jan. 1, 1987, to Dec, 31, 1997, according to the report.

The top recipient in the Senate was Richard J. Durbin (D-Ill.), who got $34,500. The Senate Republican who received the most was Charles E. Grassley (R-Iowa), with $17,000.”

ADM has been a prime beneficiary of the federal tax credit on ethanol, which the refiner can apply to the tax it pays on corporate income. First implemented in 1978, the tax credit currently stands at 51 cents per gallon of ethanol sold. The Government Accounting Office estimates the subsidies to the ethanol industry from 1980-2000 at $11 billion. As the biggest ethanol producer in the US, ADM has received the largest portion of the government's generosity.


According to the Heritage Foundation:
Senator Charles Grassley (R-IA) has extensive farm interests, as do some members of his immediate family. Listing his home address as Arlington, Vir­ginia, Grassley received $225,041 in USDA subsi­dies for corn and soybeans and disaster assistance between 1995 and 2005.[8]

In New Hartford, Iowa, Senator Grassley's son Robin has received $653,833 in subsidy payments, mostly for corn and soybeans.[9] Patrick Grassley, the Senator's grandson, who also lives in New Hartford, received $5,964 in subsidies in 2005.[10]

In 2003 an energy bill authorized $1.75 billion over seven years in "transition" assistance to MTBE manufactures, including oil companies and refiners, as they scaled back production because of state bans on the product. The bill extended a Senate-proposed federal MTBE phaseout from four years to 10 years.

The largest GOP recipient of cash who in turn supported the measure?

Chuck Grassley.


http://www.firstcoastnews.com/news/news-article.aspx?storyid=10915


Over the years Grassley has received $1.5 million in direct campaign contributions from agribusinesss and energy interests, the largest source of cash next to health insurance companies which has been part of a quid pro quo for all sorts of goodies for Iowa.

Here’s the Washington Post’s Steven Pearlstein on Grassley who objected to parts of the housing bill that might be used to underwrite failing investment banks:

Well, isn’t this rich: Max Baucus of Montana and Chuck Grassley of Iowa, chairman and ranking member, respectively, of the Senate Finance Committee are suddenly in a lather that taxpayer funds might be implicated in the Federal Reserve’s rescue of Bear Stearns.

Would that be the same Max Baucus and Chuck Grassley who have made careers out of protecting and enhancing the lavish system of import restrictions, price supports and other subsidies that have transformed American farming and ranching into a vast socialist enterprise? You betcha.

Washington Post Article


Setting aside the hypocrisy of Grassley’s inquisitions what about their legality or constitutionality. On what grounds does he request information about the funding sources or uses of funds from non-profit organizations, including churches. Should the dislike of a practice be sufficient? Should the assertion “"I have come to understand that money from the pharmaceutical industry can shape the practices of nonprofit organizations that purport to be independent in their viewpoints and actions" be grounds enough to engage in a witch hunt?

Has anyone else found it peculiar that Grassley has gone after psychiatry and churches? Is this the same as going off the deep end?

There are some on Grassley’s staff, what’s left of it, that think so:

(S)enior staffers….have have expressed profound discomfort with Senator Grassley’s actions, and wondered, rightly, whether this was not a simple assault on American religious freedom. If the United States Senate can de facto audit these preachers at whim and absent evidence of wrongdoing, what’s the barrier to doing the same to Catholics, Baptists, Anglicans, Jews, Muslims, or Mormons? Is the standard now one of mere Senatorial dislike? How is this standard not inherently politicized? The conversation ended with both of them expressing displeasure with the Senator, and grave reservations on his sense of proportion — and Constitutional propriety.

Senator Grassley is a fixture in Washington, D.C., and in Iowa politics, and so he is used to getting what he wants. But when even his own office is riven with doubts on his pet causes — on Constitutional grounds, no less — it’s time to ask the good Senator to step back, and check the hubris.”

Then again, as others have noted, you can get Grassley to see your way by making sure your solution is “Iowa-based” if you know what I mean…

The American Psychiatric Association and pharma might be able to solve their problem by dumping every dime of CME into a new Grassley Center for Continuing Medical Education at the University of Iowa which would be run out of a new building that would rise up in flood ravaged downtown Des Moines.

I bet then Grassley’s understanding of how money from pharma shapes nonprofit practices would be transformed….  Read More & Comment...

Tony Snow and Bobby Murcer

07/13/2008 02:57 PM |

Tony Snow and Bobby Murcer had a direct impact on my life.  I knew Tony a little or rather, he touched my life for the better the way he likely touched hundred of other lives.   Over 25 years ago when, as a newly minted assistant to the director of the Civil Rights Commission, holdover radicals appointed by Jimmy Carter forced me to leave for having the audacity of letting the public know certain commissioners suggesting riots were a response to President Reagan's election.  I was sitting in a vacant office at the American Enterprise Institute trying to figure out where I was going to get a job when I got a phone call from someone in the President's office named Tony Snow who then passed my name on to other people in the administration. 

Years later, when Tony was working both for USA Today and Fox he would either quote my articles or chat with me briefly.  I called to thank him and still remember the joy and enthusiasm in his voice for doing battle as well as the genuine feeling of interest he took in me and my writing.   

His turn on Fox News and as the President's press secretary gave him visibility he richly desevered.  His first love was his family and that was the focus of his efforts in the remaining years of his life.

I never knew Bobby Murcer.  As a Yankee fan I had hoped he would be the "next" Mickey Mantle.  But being Bobby Murcer was good enough.  Great clutch hitting,  Excellent outfielder and team leader.  Then being the voice of the Yankees for so many years. 
What many didn't know, even until he was diagnosed with a brain tumor, was that he devoted much of his life after baseball, to raising money for cancer research and for people in the baseball community who needed help paying for mortgages, medical bills etc. 

It has been said by some that new cancer treatments that "only" add a few months of life are not worth the cost.  I think of Tony Snow, who I know did for many what he did for me and who was able to provide for his family with the time science and G-d gave him and of Bobby Murcer who did so much for others suffering from cancer and of limited means and wonder what yardstick is applied by those who would sit on high.   We have lost two great men whose contribution to society and involvement with their families will endure and outweigh the claims imposed by people who would rob us of their presence out of cost considerations.
  Read More & Comment...

SPOT on

07/12/2008 04:37 PM |

FDA Approves New Genetic Test for Patients with Breast Cancer

The U.S. Food and Drug Administration has approved a novel genetic test for determining whether patients with breast cancer are good candidates for treatment with the drug Herceptin (trastuzumab).

The SPOT-Light HER2 CISH kit is a test that measures the number of copies of the HER2 gene in tumor tissue. This gene regulates the growth of cancer cells.

A healthy breast cell has two copies of the HER2 gene, which sends a signal to cells, telling them when to grow, divide and make repairs. Patients with breast cancer may have more copies of this HER2 gene, prompting them to overproduce HER2 protein so that more signals are sent to breast cells. As a result, the cells grow and divide much too quickly.

“When used with other clinical information and laboratory tests, this test can provide health care professionals with additional insight on treatment decisions for patients with breast cancer,” said Daniel Schultz, M.D., director of the FDA’s Center for Devices and Radiological Health.

The SPOT-Light test counts the number of HER2 genes in a small sample of removed tumor. The removed piece is stained with a chemical that causes any HER2 genes in the sample to change color. This color change can be visualized under a standard microscope, eliminating the need for the more expensive and complex fluorescent microscopes required to read assays already on the market. Unlike existing tests, the SPOT-Light allows labs to store the tissue for future reference.

Patients who over-produce HER2 protein are typically treated with the drug Herceptin, which targets HER2 protein production. This helps to stop the growth of HER2 cancer cells.

The FDA based its approval of the SPOT-Light test on a study using tumor samples from patients with breast cancer in the United States and Finland. These studies confirmed that the test was effective in determining how many HER2 genes were in these patients.

SPOT-Light is manufactured by Invitrogen Corp. of Carlsbad, Calif. Herceptin is manufactured by Genentech, of San Francisco, Calif.  Read More & Comment...

FDA Panel Votes Against Black Box on Seizure Meds: Lenzer, Brownlee Distraught No Doubt

07/11/2008 01:32 PM |

An FDA Advisory panel voted not to put a black box warning on epilepsy drugs regarding the reporting of suicidal thoughts and feelings of some taking the meds.  The reason? 

"We have to be very careful about scaring the patients into not taking these drugs, and I think we have to be very thoughtful about that," says Rochelle Caplan, MD, a professor of psychiatry at University of California Los Angeles and a member of the expert panel.

Which is precisely why people like Jeanne Lenzer, Shannon Brownlee and the crackpots who cluster at pharmalot.com push for black box warnings on all meds for mental illness and pols like Bart Stupak and Chuck Grassley seek them.  And it's why someone like Steve Nissen would use meta-analysis and press conferences to try to get them for Avandia and drugs for ADHD or demand that Vytorin be yanked from the market.

Fear mongering based on shoddy science advances a political agenda or a financial interest.  

Sadly, I am sure the expert panel exposed themselves to both abuse and threats of physical violence, often stimulated by the kind of reporting or misreporting and blogs I have mentioned above.   When chelation therapy becomes a subject of NIMH funding and black box warnings become a political tool to drive effective drugs off the market based on indiscriminate data amplified through the media and politician's press releases you know that Tabloid Medicine is replacing real science in guiding medical practice.  Once in a while you have some brave souls who follow the facts.  But for how long?
  Read More & Comment...

The Tchatchke Intifada

07/10/2008 10:14 PM |

The really sad thing about the new PhRMA marketing guidelines is that they, basically, match what Senator Charles Grassley is proposing. Talk about inside-the-Beltway groupthink.

Consider this – the big news is (are you sitting down) – no more pens or coffee mugs! Gadzooks.

(Is there a lobby for specialty goods manufacturers? We’ll soon find out.)

What's the attitude of the AMA is on this matter? It should be righteous indignation that the pfolks at PhRMA and too many members of the United States Congress, think that a physician can be bought for trinkets. Good thing these guys weren’t around for the negotiations over Manhattan Island.

But as silly and trivial as this sounds, the more serious issue at play is the caving in by the pharmaceutical industry to misguided political pressure. Silly in the instance of pens and coffee mugs perhaps – but what comes next? A “voluntary moratorium” on DTC advertising? The demonization of published articles on the off-label uses of medicines? It’s a long list.

When is a conflict not a conflict? If the answer is, “When Senator Grassley says so,” then the slope the industry is on is indeed a slippery one.

The only positive thing that will come from the Tchatchke Intifada is that pharmaceutical sales representatives won’t have to schlep them from office to office – thereby lightening their load, improving their gas mileage and decreasing the overall carbon footprint of the industry.

Where’s Nick Naylor when you need him?

  Read More & Comment...

GSK Should Be Careful What It Wishes For

07/10/2008 08:39 PM |

How naive can you get?

British pharmaceutical giant GlaxoSmithKline PLC is taking the unusual step of giving government health-care systems a say in deciding which drugs advance in its research pipeline, a move it hopes will result in more products these customers will pay for.

Glaxo's new chief executive, Andrew Witty, said the effort is part of his drive to help the world's second-largest drug maker adapt to a tough pharmaceutical market. In recent years, soaring health-care costs have led insurers, governments and other drug buyers to tighten their belts.

Was Witty really surprised then by this headline:

"The British government’s medicines advisory body has advised against the use of GlaxoSmithKline’s oral cancer drug Tyverb in the National Health Service, dealing a blow to the UK-based pharmaceutical group in its home country.

The National Institute of Health and Clinical Excellence (Nice) on Monday issued a provisional recommendation that Tyverb for advanced breast cancer did not meet its threshold for clinical and cost effectiveness. That recommendation could effectively rule out the UK market for the GSK medicine."

Tykerb is a pill that targets a subgroup of women who are HER-2 positive for breast cancer. GSK even told NICE it would only accept payment for patients who got better.

It still said no.

What new drugs do regulatory authorities want:

Close your eyes and what do you see?

Witty should know better than to hand the future of his company and that of patients over to those who care only about costs.

  Read More & Comment...

MapQuest for Medicines

07/09/2008 09:57 PM |

It’s always been more art than science to determine the point at which “approvable” letters morph into  “not-approvable” ones.  This has often been held up as Exhibit A in the lexicon of the FDA’s lack of predictability.

And now the agency has addressed it head on.  From now on there will be no more gradations of approvability.  Say hello to the “complete response” letter.

Sound familiar?  It should, it’s the same concept behind BLAs.  In other words, the agency is embracing the concept of consistency.  Good move.

Think of “complete response” letters as pathways to approval – a regulatory MapQuest for drug approvals.
And just as with MapQuest, the other most important variable in reaching the desired destination is … where you begin.    Read More & Comment...

Politico cites CMPI Biggovhealth Site

07/08/2008 02:16 PM |

  Read More & Comment...

Absence of Evidence

07/08/2008 05:20 AM |

I see the NYT is weighing in on the comparative effectiveness issue.

The first target was CT scans which we were told were a waste of money unless bureaucrats decided who got them first. Just like in the UK or Canada where people wait 18 weeks.

Second target was Avastin: The claim is that their is scanty evidence that the new drug does much more than extend lives by a few months and that the quality of life benefits are hard to measure.

The piece by Gina Kolata and Andrew Pollack could have been a lot worse but it could have been better it if had discussed the role personalized medicine will play in addressing the issues the article seems to suggest only a government agency run by economists will solve...

And what's up with their sources?

The series talks about scant evidence for cost effectiveness yet Kolata and Pollack point to NICE as an example of a government institute that decided, based on the "evidence" that Avastin not cost effective based on its cost per year of life extended. But NICE measures the value of an additional disease free year of life at $50000 which has lead them to approve birthing pools for pregnant moms and Accomplia for obese patients, a drug in clinical trials that helped people lose 9-15 lbs than with a placebo but not Avastin. Michael Rawlins the head of NICE bluntly says that the value of the additonal life year is just arbitrary. Talk about scant evidence! (By contrast Topel and Murphy, who did a systematic evaluation came up with a number of nearly $300k).

The article's experts on cost effectiveness, the consumer's providing evidence of what a complete waste of money Avastin is were Barbara Brenner of Breast Cancer Action who is notorious for campaigning against all new drugs and even early screening for breast tumors and Consumer Watchdog, which is headed up by Harvey Rosenfeld. Rosenfeld has made millions by the collection fees for bring administrative charges against insurance, HMO and drug companies in California. As a friend of the court, Consumer Watchdog also gets a cut of any successful lawsuit it participates in such as the one against Univ of Wisconsin's stem cell patents...

I don't where to begin about the claim that Avastin just prolongs life a couple of months. This is just a Grassley-fed lie.
Treating kidney cancer with Avastin prolongs progression free and overall survival by 10 and 17 months respectively compared to placebo.

In colorectal patients adding Avastin to existing treatments also added 23 months of life in peope who responded.

I could go on and will in a later post..

At the end of the day there is no evidence gap. There is a values gap. Either you believe it is worth paying for drugs to advance end stage cancer patients -- and that could be you or someone close to you -- for anywhere from a month to two years depending on how your cancer progresses or you don't. Either you believe after paying thousands of dollars of premiums and not spending much on health care you get to have a say or you don't. Either we continue to make progress, reduce death and increase survival against disease which happens incrementally, or you don't.

And the failure of Kolata and Pollack to acknowledge the promise of personalized medcine to move cancer care from hit or miss to hitting the target skewed the debate away from the science and where the discussion of health care technology assessment and Avastin in particular is already heading.

They should know better.

But it's summer and Madonna is brainwashing A-Rod with Kabbalah so they get a pass.  For now.   Read More & Comment...

MSM on Speed Dial

07/03/2008 04:23 PM |

Further to Bob's post below on Dan Carpenter's pseudo mea culpa, consider this segment from the WSJ article:

"But Mr. Carpenter stood by his conclusions, releasing a 151-page memo and his raw data on the Internet. After a detailed comparison, both sides' records turned out to have been imperfect, he said. "I'll frankly admit that we omitted four or five of the black-box warnings," Mr. Carpenter said. But the FDA "missed a whole bunch of black-box warnings" as well, he said."

Yes, well you know what they say, sins of omission are seldom fun.

"An FDA spokesman said the agency hadn't seen Dr. Carpenter's response until it received a copy from The Wall Street Journal, and hadn't had time to review it."

Sound familiar?  It's strangely  reminiscent of Dr. Nissen's rationale for why he didn't go to the FDA with his now-infamous (and discredited) meta-analysis.

Birds of a feather. Just another sad example of Tabloid Medicine.

  Read More & Comment...

Pfizer's New CME Policy: The Sum of All Fears

07/03/2008 03:37 PM |

According to the logic of Pfizer's new CME policy, commercial speech should be discontinued because of the appearance of conflict of interest. Or rather, the content of commercial speech -- and the freedom to pursue -- shall now be abridged by those who define what the conflict is, namely the academic medical centers, who will also get the cash that once went to for profit companies. Put another way:

Is there a difference in the quality of communication when money is given to a non-profit provider of information, especially when that money is shifted from the objects of criticism to the critics? Or is this simply a matter of turning medical education into hush money?

Can academic medical centers, who have treated primary care issues and primary care physicians as abused stepchildren, really run top quality CME programs? Can medical societies, usually staffed by two people and a temp do the job?

CME is too important -- particularly for the minority community -- to be left to amateurs who think it is a dirty business, not an important component of the public health.

It's one thing to insure that CME is objective and made widely available and affordable to as many clinicians as possible using both online and in person formats. It's another thing to shut down an important avenue for disseminating information: for-profit organizations.

The last time I checked medical schools and AMCs were for grabbing tuition, grants, fees, endowments, spending millions on marketing, ads, endorsements, wooing high profile specialists and practices. And they make no bones making people like you and me, when we have no insurance, paying upfront and top dollar for the quality care the advertise on TV and on the visors they give away at baseball games.

Somehow when a drug company wants to spend millions to educate doctors, not on their drugs, but on disease management, that's a scummy thing to do.

I am sick and tired of the pontification on the one hand and the pharmaceutical cowardice on the other.

Caving in does not buy peace, it only prompts more attacks.

As Thomas Jefferson observed: "A coward is much more exposed to quarrels than a man of spirit. "  Read More & Comment...

A Carpenter's Shoddy Hit Job

07/03/2008 12:44 PM |

Sometimes when you do a hit job on someone you get caught, especially if your target is Bob Temple.  Daniel Carpenter and the self-serving Jerry Avorn tried to claim that there was a higher incidence of black box warnings around drugs approved right before user fee deadlines (they used 2 weeks, an artificial number) than what they considered routine (I guess that means two weeks and one day). 

They got caught when Temple and FDA economists found significant, uh, omissions in their daabase and "rounding" errors that when accounted for essentially eliminated any difference in the number of black box warnings. 

According to the WSJ Carpenter and Avorn did a fix.  If you read the NEJM apology for getting caught by Temple the Carpenter and Avorn fix is this:  they just add new black box warnings gleaned from the "addition of data through December 2007"  Ta-da!  They "found more modest but still significant association between just-before-deadline approvals and safety problems."

Here's the trick:  The black-boxing of a drug is a response to policy pressure as much as  writing an article about black boxes is.  Adding data throughout 2007, when pressure was on the FDA to ADD black box warnings from Grassley and others, data that is not included in  Temple's analysis is a sure-fire way to demonstrate "significant associations."  Even the sloppy Carpenter and Avon admit: most of this difference stems from the different time frames used in the two analyses.

But the media will likelly not pick up on this.  After all the headline of the WSJ article regarding this issue is: Scholar Fixes Flaws, Defends Finding of FDA Errors In Too-Hasty Approvals
The WSJ article missed the sleight of hand Carpenter and Avorn use to 'fix' things...   Read More & Comment...