Big Pharma Reading Political Tea Leaves and Increasingly, Sees Democrats

With the Iowa Caucuses a mere few days away, and the New Hampshire primaries to follow shortly thereafter, I thought it might be interesting to see what the U.S. pharmaceutical industry thinks about the 2008 election. The real question is whether it even matters? I cannot answer that question today, but I can provide some perspective on what the American drug industry is thinking.

The pharmaceutical and health-products industry has spent more on lobbying Washington –- $1.1 billion -– since 1998 than any other industry, according to the Center for Responsive Politics, which analyzes lobbying disclosure reports. Over two-thirds of the more than $90 million the drug industry has contributed to Congress since 1994 went to Republicans, according to the Center for Responsive Politics. Critics of the pharmaceutical industry argue that heavy spending on lobbyists and campaign contributions is a big reason drug companies have gotten much of what they've sought in Congress and from the President in recent years. Consider the Medicare Drug Benefit as an obvious example of corporate welfare at the taxpayers' expense.

Although it's unclear what pharmaceuticals have to do with protecting the U.S. from terrorist attacks, it did not stop President Bush from naming Eli Lilly and Company's (soon to be former) CEO Sidney Taurel as one of his Homeland Security Advisory Council members, and more recently, Bush appointed him to the senior trade advisory panel. Lilly's ties to the Bush family are well-documented. But Lilly's Red State Republican support extends well beyond the Bush family.

According to USA Today, since at least 1980, the Indianapolis-based insulin manufacturer has given at least 65% of its PAC contributions to Republicans, according to PoliticalMoneyLine, a non-partisan company that tracks campaign contributions. Lilly is a major donor, giving more than $50,000 in contributions during the 2006 election cycle, the fourth highest among corporate health care PACs, again, according to PoliticalMoneyLine.

But as The Wall Street Journal recently reported, for a variety of reasons, it's beginning to look like the "GOP Is Losing Grip On Core Business Vote", and that apparently includes Big Pharma as well. In spite of huge benefits the Republican party has handed to the pharmaceutical industry (like the provisions of the Medicare drug bill that prevent the agency from seeking competitive bids or the refusal to allow drugs to be re-imported from Canada), that did not help Republicans in the 2006 election, when voters switched Congressional majorities from Republican to Democrat.

These days, it's starting to look like Big Pharma is what could best be described as a "fair weather friend" to the Republican party. Using Lilly as an example, during the first four months of 2007, the company gave slightly more money to congressional Democrats ($29,500) than to Republicans ($28,500). One could make an argument that Lilly was merely reading the political tea leaves and shifted its corporate lobbying strategy to reflect that. But Lilly is hardly alone among big drug companies. ALL told, according to The Center for Responsive Politics, pharmaceutical manufacturers have given $154,710 to Obama, $140,544 to Clinton, $103,825 to Mitt Romney, $91,550 to Rudy Giuliani, and $68,200 to Chris Dodd. By comparison, Republican John McCain received $39,797.

Dr. Peter Rost, formerly of the blog BrandWeekNRx reported that Pfizer CEO Jeff Kindler apparently supports Hillary Clinton for president in 2008. Dr. Rost says "This is an abrupt departure from the path taken by Kindler's predecessor, Hank McKinnell, who was a Bush ranger and right-wing Republican." Rost speculated that since Kindler is a lawyer, and the trial bar often supports Democrats, his position may not be all that surprising – if it wasn't for the fact that he is now CEO of Pfizer and used to work for McKinnell and did McKinnell's bidding to get Pfizer employees to vote for Bush. Rost comments that if the big drug companies are now supporting Hillary Clinton, she sure has come a long way since she tried to implement healthcare reform, and that's good news for Mrs. Clinton's Presidential campaign.

This may be a victory for Mrs. Clinton, but is it a victory for the American voter? Clinton is decidedly centrist, which, according to some political analysts (like her husband) is what's needed if she is to win some of the red states she needs to win the Presidency. To be sure, while that annoys the heck out some leftists within the Democratic party, if she wins the primary, they may have to support her in the absence of having any other alternative. Another negative is that she talks ad nauseam about her learning from the 1993 Health Care debacle, and that has made her unwilling to rock the establishment too much. But then again, in her proposed healthcare plan, she is one of the only candidates to state something about not allowing insurance companies to "cherry pick" and with her plan, Mrs. Clinton notes that people with pre-existing conditions would be offered insurance on a par with others, "prohibiting insurance companies from carving out benefits or charging higher rates to people with health problems." Many people with diabetes should be looking for a health plan that does this.

Also, in February 2007, Senator Clinton along with Senator Charles Schumer (D-NY) and Representative Henry Waxman (D-CA) introduced legislation which I firmly support and hope will be voted on and signed into early next year. That bill (S. 623/H.R. 1038, the "Access to Life-Saving Medicine Act of 2007") would give the FDA the legal authority to approve cheaper, generic versions of biotech drugs known as biologics or follow-on protein products, something the FDA has refused to address unless they did so under court orders.

As my article on this subject noted, insulin has been caught up in the FDA's refusal to outline procedures for generics manufacturers to get approvals, and this bill would help open the doors to more competition in the insulin market, which is arguably a cartel that is more similar to the U.S. auto industry in the late 1970's than it is the U.S. long-distance telecommunications industry in the 1990's. Today's insulin market has little product innovation, a lot of price gouging, mediocre quality and marketing arrogance, and the executives from the three major manufacturers do not hide their intention to eliminate all forms of human insulin from the market, leaving us with only costly insulin analogs with questionable long-term safety results. This is obviously meant to benefit shareholders, but isn't necessarily in the best interest of patients.

Representative Waxman, a California Democrat who is now chairman of the House Oversight and Government Reform Committee, introduced similar legislation in 2006, but his bill was never voted on. The new bill, if approved and signed into law, would change U.S. patent laws under the 1946 Public Health Services Act that now prevents the FDA from approving some generic versions of biotech drugs and require the FDA to outline procedures to get these medicines approved. The bill would give the FDA the express legal authority to approve generic biotech drugs, and in many cases, remove the need for expensive and time-consuming repetition of clinical trials. The FDA would also be given the authority to decide on a case-by-case basis what additional clinical information is required before approval will be granted. Also, in an effort to avoid the various legal loopholes that now delays FDA approval of many generic chemical drugs, this legislation also calls for timely resolution of patent disputes. As several bloggers have noted, a vote on this bill was delayed due to lobbying, but since the bill seems to enjoy widespread bipartisan support, it seems almost certain to emerge in the 2008 legislative session.

To be sure, not all of Big Pharma and the Diabusiness Industry is supporting Clinton or the Democrats. For example, glucose test strip manufacturer (among their many products) Abbott Laboratories' CEO Miles White donated $15,000 to the Republican Party of Illinois (where Abbott is headquartered), $5,000 to the National Republican Congressional Committee, and smaller donations to Senator Ted Stevens (R-AK), Congressman Mark Kirk (R-IL) and Republican presidential candidate Mitt Romney. Others either haven't yet supported anyone, or the company does not officially support political candidates.

But it does look as if the fair-weather Republican friends in Big Pharma are dwindling in numbers as the political tides turn. 2008's election should be interesting to say the very least, especially considering the dramatic changes we're witnessing in primary dates being changed, but the real question we should be asking is just how significant are the differences between each of the candidates -- and that includes differences across party lines? Many people see few substantial differences between the candidates from the two major parties. But don't let that stop you from exercising your right to vote and let your voice be heard in the elections!

Part 2: Your Rx Buying History is For Sale

I didn't expect to post anything before next week, but again, my scan of today's news made that impossible! I'll start with some background info. first, and then give you the story that made the news yesterday right after that.

Back in November, I posted a story about how patientprivacyrights.org started a new campaign to call attention to the fact that your prescription drug buying history -- including your name, address, date of birth and drug regimen is FOR SALE. Each day virtually all of the 51,000 pharmacies in the U.S. download, transmit and sell personally identifiable information for every drug they disburse. The primary recipients of that data include companies such as IMS Health of Norwalk, Conn., Wolters Kluwer Health of Conshohocken, Pa., and Verispan of Yardley, Pa., all of whom collect, analyze and sell medical data to drug companies, government agencies and researchers, often at very high prices.

Patientprivacyrights.org has done a great job communicating this issue, including the following video:



Strike 1: New Hampshire, April 30, 2007

Some states have passed laws to prevent the distribution of information you never agreed to (or even waived your rights to) share. In particular, the states in northern New England have been especially aggressive in trying to limit this invasion of patient and physician privacy. According to the National Conference of State Legislatures, a number of other states were also considering similar proposals. But these state efforts have been repeatedly challenged in Federal courts on the grounds that the laws are NOT permitted according to Federal laws, therefore the state laws have been struck down by the courts.

For example, in April 2007, Judge Paul Barbadoro of United States District Court in Concord, N.H. ruled that the pharmaceutical industry could continue to use computerized data showing which doctors are prescribing what drugs. This is used to sell drugs, not monitor the safety of those drugs. Yet the data aggregators are claiming these law will "prevent the health care community from monitoring the safety of new drugs". Certainly it is a clever argument, even if it is a misrepresentation (some would argue an outright lie) of what is really happening. New Hampshire was sued by two data mining corporations (IMS Health and Verispan). One of those corporations reported revenue of $1.75 billion in 2005, and not a dime was used to help a single sick person. If you need any evidence, just look at the Avandia controversy earlier this year and you'll have a more complete picture. But Judge Barbadoro struck down the New Hampshire law which prohibited the purchase and resale of the data for use by the drug makers. The judge said that the law violated the First Amendment by "restricting commercial speech". A similar case is also pending now in neighboring Vermont. The full story on the Federal court ruling in New Hampshire was documented in The New York Times, and can be read here.

Strike 2: Maine, December 21, 2007

New Hampshire's eastern neighbor, Maine, tried a slightly different tact. The Maine law had been urged by doctors who objected to the sharing of their prescribing patterns, and instead of prohibiting the sale of prescription data, it was supposed to enable individual doctors to designate a prescription as "confidential" so it could not be shared or sold without the doctor's permission. Unfortunately, yesterday, U.S. District Judge John Woodcock concluded that the Maine law, which was scheduled to take effect Jan. 1, would prohibit "the transfer of truthful commercial information" and "violate the free speech guarantee of the First Amendment." In effect, he ruled that making doctors' prescription-writing habits confidential violated the U.S. Constitution. My own take is that free speech for commercial entities is apparently protected, while individual free speech is not.

Judge Woodcock, in a 42-page decision, said that he relied heavily on the April 30 ruling by U.S. District Judge Paul Barbadoro in New Hampshire that shot down a similar law in that state. Of course, the New Hampshire law is still pending an appeal, and the primary sponsor of Maine's legislation, Democratic Rep. Sharon Treat, said that she was disappointed with the ruling, but also anticipates an appeal. Appeals by Maine and New Hampshire could be consolidated if judges at the 1st U.S. Circuit Court of Appeals find that they involved similar issues.

For more details, I am including the full story details below, but there is something you can do about this, so be sure to continue to the end of the page!

Judge Overturns Maine Law on Rx Data
Associated Press
2:14 PM EST, December 22, 2007

BANGOR, Maine - A federal judge has ruled that a new Maine law making doctors' prescription-writing habits confidential violates the Constitution.

U.S. District Judge John Woodcock concluded that the law, which was scheduled to take effect Jan. 1, would prohibit "the transfer of truthful commercial information" and "violate the free speech guarantee of the First Amendment."

The law had been challenged by IMS Health of Norwalk, Conn., Wolters Kluwer Health of Conshohocken, Pa., and Verispan of Yardley, Pa., which collect, analyze and sell medical data to pharmaceutical companies, government agencies and researchers.

The companies said the law would prevent the health care community from monitoring the safety of new drugs. Backers of the measure say it is one of several new laws passed by Maine legislators that aim to address high health care and prescription drug costs.

In a 42-page decision issued Friday, Woodcock said he relied heavily on an April 30 ruling by U.S. District Judge Paul Barbadoro in New Hampshire that shot down a similar law in that state. A similar case is also pending in Vermont.

The primary sponsor of Maine's legislation, Democratic Rep. Sharon Treat, said she was disappointed with the ruling and anticipates an appeal.

What You Can Do

It seems very clear that the only way for this issue to be resolved effectively is not in statehouses across the country, but in U.S. Congress in Washington. Unfortunately, most plans (even those offered by Congressional Democrats) give only lip service to the linchpin of system reform: the restoration and preservation of patient privacy. This bedrock principle is hard to overlook, yet most of the competing plans on the presidential debate circuit are conspicuously silent as to how patients' privacy will be protected from exploitation.

Dr. Deborah Peel, of the Coalition for Patient Privacy, asserts, "HMOs, the insurance industry, employers, marketing firms, the drug industry, banks and financial institutions, and the data aggregating industry all view health care 'reform' as a golden opportunity to strengthen and extend the authority HIPAA granted them to steal every American's sensitive health data. The primary use of electronic health records today is for sale or use by corporation for purposes that do nothing to improve health."

Sign the Petition

A great place to start is by visiting Coalition for Patient Privacy website here. Sign their petition and urge your Congressmen (and women) that you want control over who can see and use your medical records, including your prescription purchasing behavior. Its up to you!

2007 Seasons Greetings from U.S. Congress!

Well, as some of my readers may have noticed, I hadn't posted anything this week, which is unusual unless I'm traveling. I was going to cop-out today and post a holiday meme or something, but in my scan of this morning's news, I learned that legislation I wrote about in November actually passed in Congress yesterday. I was expecting that like many other bills pending, this one would be delayed until 2008 since Congress hasn't accomplished a tremendous amount in recent months, and much of what they did accomplish only passed because of tremendous lobbying (by both professional lobbyists and citizen advocacy groups).

The legislation I'm referring to would require scientists getting grant money from the National Institutes of Health (NIH) to submit to the NIH a final copy of their research papers when those papers are accepted for publication in a journal. An NIH database would then post those papers, free to the public, within 12 months after publication. The current NIH Public Access Policy, which was first implemented in 2005, is a strictly voluntary measure and has resulted in a deposit rate of less than 5% by individual investigators. Presently, billions of dollars ($29 billion to be exact, according to Heather Joseph, executive director of the Scholarly Publishing and Academic Resources Coalition) in research are paid for by U.S. taxpayers, but the results of those studies are often restricted to subscribers of expensive medical and scientific journals.

Those taxpayer-funded scientific and medical results are instead available for a fee by the publishers, often $29 or more for a single article! Even more troubling is the fact that much of this taxpayer-funded research benefits for-profit, multinational publishing companies like Elsevier, Wiley/Blackwell, Wolters Kluwer and others, not nonprofit groups of scientists and/or doctors who have traditionally published these journals. This morning's edition of The Washington Post reported that "a provision that would give the public free access to the results of federally-funded biomedical research [in PubMed Central] represents a sweet victory for a coalition of researchers and activists who lobbied for the language for years".

This is indeed an end-of-year victory for all of us, particularly since the funding bill is unlikely to be vetoed by President George W. Bush because there are almost no restrictions on his war-funding included. The only downside is that it may take 6 months before the NIH figures out how to implement the new requirement. I'm including the full article below for your reference. I will likely not be posting much more until after the Christmas holiday, so I'd like to wish everyone seasons greetings!




Measure Would Require Free Access To Results of NIH-Funded Research
By Rick Weiss, Washington Post Staff Writer
Friday, December 21, 2007; Page A33

It is barely a drop of ink in the gargantuan omnibus spending bill that Congress just passed. But a provision that would give the public free access to the results of federally funded biomedical research represents a sweet victory for a coalition of researchers and activists who lobbied for the language for years.

Under the bill's terms, scientists getting grant money from the National Institutes of Health would now have to submit to the NIH a final copy of their research papers when those papers are accepted for publication in a journal. An NIH database would then post those papers, free to the public, within 12 months after publication.

The idea is that taxpayers, who have already paid for the research, should not have to subscribe to expensive scientific journals to read about the results.

That populist line -- spearheaded by patient advocacy groups seeking easier access to the latest medical findings and supported by libraries whose budgets have had trouble keeping up with rising journal subscription costs -- ultimately overwhelmed objections from journal publishers. Those firms had complained bitterly that proponents bypassed the congressional committees that could have carefully compared the new approach to less disruptive systems for making information available to the public, some of which are already being used by other science-funding agencies.

Among the publishers' concerns are that they would lose income from paid subscriptions, which would undermine their ability to sponsor educational activities and peer reviews. Of equal concern, they say, the policy may violate copyright law, a potential legal tangle that some hinted yesterday might have to get sorted out in court.

"The issue isn't finished yet," said Allan R. Adler, vice president for legal and governmental affairs at the Association of American Publishers, which lobbied hard against passage. "It's not as simple as some have made this out to be."

That attitude sounded Grinch-like to Heather Joseph, executive director of the Scholarly Publishing and Academic Resources Coalition, which led the fight for the open-access language.

"The basic reason we went to bat so hard for this was because we thought it was the right thing to do with taxpayers' science," Joseph said. "Now there will be $29 billion in taxpayer investments freely available to the public," she said, referring to the NIH medical research budget.

The NIH has had a voluntary program in place since 2005 encouraging grantees to submit their final manuscripts to a publicly accessible database within a year of publication. Agency officials have contended that journals would lose few subscribers because most scientists would not want to wait a year before reading about new research and because NIH-funded research is but a small fraction what most journals offer on their pages.

But as of September, only about 5 percent of eligible scientists have bothered to participate in the voluntary system. That inspired proponents to push for the congressional mandate.

"Mandatory deposition is a natural next step in NIH's efforts to ensure public access to the research it funds," said Matthew Cockerill, publisher of BioMed Central, which publishes more than 180 online scientific journals.

Cockerill noted that other major funders of research, including the Howard Hughes Medical Institute, based in Chevy Chase, and the Medical Research Council in Britain, recently instituted similar open-access requirements for grantees.

The NIH will now start working out how to implement the legislation, a process that could take six months, said John Burklow, NIH communications director. "Our main goal right now is to make sure everyone understands the policy and knows how to follow it" once it comes into effect, he said.

URL for this article:
http://www.washingtonpost.com/wp-dyn/content/article/2007/12/20/AR2007122002115.html

Should the U.S. Consider "The Health Care Choice Act"?

The U.S. healthcare insurance industry has a variety of issues impacting both cost and availability. One issue that is seldom mentioned is that although interstate commerce in goods and services is fairly routine in most other areas of the national economy (including banking and financial services, since the Gramm-Leach-Bliley Financial Services Modernization Act of 1999, anyway), the insurance industry, and more specifically the healthcare sector is governed by a confusing patchwork of various state laws and inconsistent government regulations, all of which impacts costs and availability. This means that individuals and families are unable to secure the kind of coverage they want at the prices they wish to pay, and companies struggle with how to offer coverage that addresses the mandates required by many different states.

Legislation called The Health Care Choice Act has been introduced repeatedly since 2005, but wasn't voted on, so the bill therefore died in the House and/or Senate, or in previous iterations, failed to secure sufficient support to pass. Think about this for a moment, and consider what happens when different laws across states exist. Before Gramm-Leach-Bliley existed, banks were regulated at the state level. Thats one reason most credit cards come from banks chartered in Delaware, South Dakota, or more recently, Arizona. The reason is that in the 1970's, those states had no interest rate caps and low taxes on banks, which made them attractive for bank holding companies to charter their credit card divisions in those states, and Supreme Court decisions enabling banks to "export" card terms to other states paved the way for that to happen. But the real impact was a standardization of practices across the industry, rather than banks in California being governed by one set of laws and banks in New York governed by another set of laws. The fact that American consumers will have received some 8.5 billion credit card solicitations during 2007 suggests that it is a competitive market. Having a national marketplace for healthcare insurance would likely introduce competition to a market that is largely uncompetitive today.

Compare that to the current situation. Suppose you wish to buy a healthcare insurance policy (assuming for a moment that you don't need to worry about preexisting condition exclusions). It is known that in addition to rates varying from one part of the country to the next, there are also various state coverage mandates on healthcare insurance, which force buyers to pay more for insurance - or else go without insurance at all. According to a study undertaken by the Council for Affordable Health Insurance, in 2006, state laws and regulations included, nationwide, some 1,824 benefit mandates. The number of mandates varies considerably. For example, Idaho only has 13 mandates, while Minnesota imposes a whopping 62 mandates. To add to the complexity, no two states impose the same set of mandates. One of the better known mandates requires insurers to cover diabetes supplies (which at last count was mandated in something like 45 states). While critics complain that mandates like this raises costs for those who don't need these services, there is plenty of this type of unfairness to go around. For example, more than 40 states mandate coverage of adopted children. For those who do not adopt children or have no children at all, this type of mandate is seen as wasteful.

There is no denying that having a national market for healthcare insurance would almost certainly create a "lowest common denominator" effect, but this would nevertheless enable policies to be more uniform on a national scale, reduce administration cost of complying with 52 sets of different laws (including Puerto Rico and the District of Columbia). Decisions regarding mandates could be decided on a national level, rather than having inconsistent coverage because we have crossed state lines. The net impact could be a reduction in costs, which virtually everyone acknowledges is badly needed.

Personally, I think we should be exploring this and other possibilities. While Congress wants to move on the Wired for Healthcare Act, which would create electronic health records for every American, aside from the security concerns and the lack of dispute resolution processes, there is absolutely no clinical evidence that this type of legislation will reduce costs or reduce errors as that bill's supporters claim. But we do know that having a national marketplace for insurance does reduce costs and standardizes availability. This alone will not solve the nation's healthcare crisis, but it most certainly will contribute towards addressing the numerous problems with ever-escalating costs which now exist. At the very least, it deserves an honest look and discussion.


A Health-Insurance Solution
By Merrill Mathews, The Wall Street Journal
December 12, 2007; Page A18

Why can't people living in New Jersey buy health insurance available to residents of, say, Pennsylvania?

Rep. John Shadegg, an Arizona Republican, thinks they should -- and today will reintroduce legislation to make that possible.

The Health Care Choice Act would allow residents in one state to buy health insurance that is available in and regulated by another state. If enacted, the law would create a competitive, 50-state market for health insurance, likely making it cheaper. It would do this without imposing a large cost on taxpayers and without creating a new government bureaucracy.

This should be a no-brainer for Congress. But a few years ago, Mr. Shadegg went looking for a Democratic cosponsor for his bill. He found one who initially signed on, then withdrew under pressure from Democratic House leaders who wanted to dismiss the Shadegg bill with the excuse that it lacked bipartisan support.

The health-insurance market can be divided into three segments. The first consists of mostly large employers, with self-funded plans, and are regulated by the federal Employee Retirement Income Security Act (ERISA) and thus not subject to state regulation. The two remaining segments of the health-insurance market are heavily regulated by states: those that serve small-group plans (typically covering two to 50 people), and individuals who pay for their own insurance. Mr. Shadegg's bill only applies to the individual market.

Because regulations vary from state to state, the cost of health insurance for these last two segments of the insurance market vary widely. Some states ensure that residents have access to a wide range of affordable policies. Others -- New Jersey, New York, Massachusetts, for instance -- have all but destroyed their individual health-insurance markets with over-regulation.

One of the most expensive state-level regulations is "guaranteed issue," which requires insurers to sell insurance to anyone willing to buy it, regardless of their health, or other factors that may make it much more expensive to cover them. New Jersey, for example, enacted guaranteed issue in 1994. At the time, a family policy could be purchased in the state for as little as $463 a month or as much as $1,076, depending on which of the 14 participating insurers a family chose. Now there are just 10 insurance companies offering plans in the state and the cost has soared to $1,726 per month on the low end and $14,062 on the high end.

In New Jersey then, residents who buy their own insurance have to pay at least $20,000 a year for the cheapest family policy. Meanwhile, in neighboring Pennsylvania similar health-insurance policies cost a third of what they cost in New Jersey. What Mr. Shadegg wants to do is to let New Jersey residents buy what's now for sale in Pennsylvania.

Mandates are another reason the cost of health insurance varies from state to state. States impose those mandates on what an insurance plan must cover -- such as chiropractic care or mental-health services. The Council for Affordable Health Insurance, which tracks mandates, estimates that there are more than 1,900 state mandates nationwide. These mandates can increase the cost of health insurance by as much as 50%, which can then force residents in many states to decide between "Cadillac coverage" -- insurance that covers nearly everything and costs a mini fortune -- or no coverage at all.

Typically, state mandates are justified by the belief that they make health insurance more comprehensive. But consider this: Idaho has just 14 state mandates, the fewest in the nation, while Minnesota, with 63, has the most. Yet, the people of Idaho aren't dying in the streets for lack of mandates.

Critics of the Health Care Choice Act claim that it would limit the ability of states to protect their residents. The assertion is that cross-state health-insurance purchases are a risky experiment. In truth, millions of people already have access to health insurance across state lines. Employees of large companies with plans covered by ERISA are one example.

But there are others. Some small businesses cover employees working across state lines. And, because people are mobile, some people buy individual insurance in one state and then end up moving to another. In many cases, they can take their health-insurance policies with them. A person living in Pennsylvania with an individual policy now could retain that policy even if he moved to New Jersey. Premiums would likely increase, but they would be cheaper than if he had started out with a New Jersey policy.

If states are worried about losing regulatory control over health insurance, they might try making their regulations competitive with other states. Health insurers would likely respond by returning and offering a wide range of affordable policies. As it stands, many states are "protecting" their residents right into the uninsured camp.

The Health Care Choice Act won't solve every problem. But it would increase competition and consumer choices currently denied to residents in many states.

Mr. Matthews is executive director of the Council for Affordable Health Insurance and a resident scholar with the Institute for Policy Innovation.

URL for this article:
http://online.wsj.com/article/SB119742880091722751.html

More Discrediting of "Disease Management" Programs

There is growing evidence that so-called "disease management" programs do not prove their worth, at least in terms of saving money on healthcare spending. According to a study issued by the RAND Corporation, such programs appear to improve the quality of health care, but there is little evidence that such efforts actually save money. The RAND study is not the first to raise this question. A 2004 report from the Congressional Budget Office (CBO) raised its own concerns, saying that there was "insufficient evidence" that disease management programs can reduce overall health spending, or generate savings for federal health programs such as Medicare, which prompted a bigger investigation into the issue. Diabetes is perhaps the condition most often targeted by such disease management programs because it is relatively easy to do a glycosated hemoglobin (better known as the hemoglobin A1C) blood test to show reported progress (or lack thereof), while other chronic conditions are more difficult to quantify results.

A 2004 article published in The Wall Street Journal cited statistics from Mercer Human Resources Consulting which indicated a growing percentage of employer-sponsored health plans were offering disease-management programs. A more recent article indicates that health insurance plans and employers nationally in 2005 spent about $1.2 billion on disease management programs, with 96% of the top 150 U.S. health insurance companies offering some form of "disease management" program, apparently with little to show for that investment. Most health plans outsource such work to more than 100 companies that have crowded into the market. Typically, chronically ill patients are monitored over the phone via nurse call centers, which work with information provided by labs, doctors and pharmacies. But these plans sometimes use automated response systems to check on patients, rather than actual people. The evidence also suggests that disease-management programs have been expanded to include depression, cancer, kidney disease, obesity and lower-back pain. But money talks, and the dollars being spent on these programs have yet to prove their worth.

The next time your healthcare provider wants to enroll you in a "disease management" plan to help you manage your diabetes, you may want to decline it, citing the statistics provided in these two articles. The bigger question is why we continue to spend our scarce healthcare dollars on these plans, which based on personal experience with them, annoy patients yet provide little in the way of assistance in actually managing chronic illnesses? The evidence is mounting that they do little to help improve healthcare, or save money.

I am including two articles which raise questions on these programs, the first one being very recent, the latter dating back to October 2004 but surprisingly, most of which is still very relevant, even today.



Disease Management Programs
December 11, 2007

Disease management programs that help guide the care of patients with chronic health problems appear to improve the quality of health care, but there is little evidence that such efforts actually save money, according to a study issued by the RAND Corporation.

The RAND Health study reviewed all past research on disease management programs, which seek to help patients with conditions like diabetes and congestive heart failure by offering a system of coordinated healthcare interventions. These interventions can range from pre-recorded telephone reminders to home visits by medical professionals.

Researchers selected 29 evaluations, systemic reviews and meta-analyses to focus on, covering 317 unique studies. That review found consistent evidence that these programs can improve health care quality, improve disease control, and, in the case of patients with congestive heart failure, reduce hospital admission rates. But patients with depression who were enrolled in disease management programs were more likely to use outpatient care and prescription drugs, increasing costs. There also is little evidence about whether these programs improve health outcomes over the long term.

"Disease management is viewed as the silver bullet that can fix two problems of the health care system -inadequate quality and high costs," said Soeren Mattke, lead author of the report and a senior natural scientist at RAND, a nonprofit research organization. "Unfortunately, while there is evidence that disease management programs can indeed improve the quality of care, there is no conclusive evidence that they can actually save money."

Health insurance plans and employers nationally in 2005 spent about $1.2 billion on disease management programs, with 96% of the top 150 U.S. health insurance companies offering some form of disease management service. The topic also has become a key point in the national health care reform debate, as policymakers search for a way to improve health care quality and access, while controlling costs at the same time.

The RAND study analyzed research on various disease management programs and their effect on six chronic conditions: congestive heart failure, coronary artery disease, diabetes, asthma, depression and chronic obstructive pulmonary disease. With the exception of asthma and chronic obstructive pulmonary disease, which showed inconclusive results, researchers found consistent evidence that disease management programs did improve the quality of health care. There also was consistent evidence that patients with congestive heart failure and depression reported improved quality of life.

But evidence of cost-savings was inconclusive for most of the conditions, indicating that further research is needed. It is plausible that disease management programs reduce costs for congestive heart failure patients because many programs reduce hospital admissions for these patients, Mattke said. In contrast, research has shown that patients with depression are commonly under-treated, so a disease management program that actively screens for depression and encourages patients to get treatment will increase costs.

Most of the studies Mattke and his colleagues reviewed followed patients only for about a year, which is not long enough to assess long-term health outcomes. For example, a disease management program may improve a patient's cholesterol levels in the short term, but it can take years to determine whether those interventions -- assuming they were sustained for a long period -- prevent heart attacks and costly hospitalizations years into the future.

"People take for granted that these programs work and save money, because the concept is very plausible," Mattke said. "But many things in medicine sound plausible until you do the research and find that promises don't hold true."

Health insurance plans, employers and policymakers also will have to evaluate whether the benefits of disease management programs are worthwhile, despite the lack of evidence for cost-savings, Mattke said.

Another factor is that "disease management" itself is not well-defined, Mattke said. The types of interventions can vary from congestive heart failure specialists at a local hospital hiring a nurse to educate patients about preventive care to large-scale programs reaching thousands of patients. Some programs may be better than others, but there has not been enough research to properly assess which ones are the most effective or what characteristics are associated with more successful programs.

"Just because one type of intervention can benefit one disease, that doesn't mean it will work the same way for another disease," Mattke said. "Most of the evidence for disease management comes from small provider-centered programs at academic medical centers or multi-specialty groups."

The study, "Evidence for the Effect of Disease Management: Is $1 Billion a Year a Good Investment?" will appear in the December issue of The American Journal of Managed Care. The other authors of the study are Michael Seid of Cincinnati Children's Hospital, and Sai Ma of Johns Hopkins Bloomberg School of Public Health.

RAND Health, a division of RAND, is the nation's largest independent health policy research program, with a broad research portfolio that focuses on health care quality, costs and delivery, among other topics.

The RAND Corporation is a nonprofit research organization providing objective analysis and effective solutions that address the challenges facing the public and private sectors around the world.

Source: Lisa Sodders, RAND Corporation. Article adapted by Medical News Today from original press release.

URL for this article:
http://www.medicalnewstoday.com/articles/91402.php


The Informed Patient: "Does Disease Management Pay Off?"
By Laura Landro, The Wall Street Journal
October 20, 2004

A growing number of disease-management programs offer to monitor patients with chronic conditions and help avoid dangerous complications that might lead to catastrophic and expensive illnesses tomorrow. But the long-term cost effectiveness of such programs has been hard to measure -- and that is raising some thorny issues in the debate over how to contain health-care costs.

By most estimates, people with chronic diseases account for more than two-thirds of the nation's $1.6 trillion medical bill, a figure that is expected to grow as baby boomers age. The aim of disease management, whether through the family doctor or a health-plan service, is to educate patients about their disease and help them manage its symptoms, such as controlling blood sugar in diabetics to stave off blindness, kidney failure and amputations.

The percentage of employer-sponsored health plans offering disease-management programs grew to 58% last year from 41% the year before, according to Mercer Human Resources Consulting. A number of health plans outsource such work to more than 100 companies that have crowded into the market. Typically, chronically ill patients are monitored over the phone via nurse call centers, which work with information provided by labs, doctors and pharmacies. Disease-management programs are now expanding to include depression, cancer, kidney disease, obesity and lower-back pain.

There is plenty of evidence to show that taking better care of chronically ill patients can improve the quality of life, slow the progression of disease and reduce hospitalizations. "We've made real progress in keeping people healthier who have chronic illnesses," says Edward Wagner, director of the MacColl Institute for Healthcare Innovation at the nonprofit Group Health Cooperative's Center for Health Studies in Seattle. "But we still don't know definitively what the economic impacts of disease management are."

While he supports doctors' efforts to help their own patients manage disease, Dr. Wagner expresses skepticism about outsourced disease-management programs, which sometimes use automated response systems to check on patients. Hands-on efforts "should not be mixed up with the more expensive and more visible activities of disease-management vendors, where evidence has been very flimsy," Dr. Wagner says.

Last week, the Congressional Budget Office raised its own concerns, saying in a new report that there is insufficient evidence that disease management can reduce overall health spending, or generate savings for federal health programs such as Medicare, which covers the oldest and sickest patients. While the CBO report says disease-management programs can be worthwhile even if they don't reduce costs, it notes that there haven't yet been enough broad population-based studies or clinical trials to demonstrate that disease-management programs cut costs -- and there is a chance disease-management programs could actually raise costs by increasing the amount of medical care patients use.

The report touches on delicate subjects. For example, staving off health problems of chronically ill patients can improve and extend life, but the longer a patient lives, the report notes, the more likely he or she is to die later of more serious illnesses, such as cancer, which cost more to treat.

Medicare is about to launch an ambitious pilot program to test disease-management programs. That plan is expected to include about 10 to 12 different sites around the country, covering 20,000 or more patients each. The CBO says it will monitor that study, using it to help weigh the costs versus benefits.

Christobel Selecky, president of the
Disease Management Association of America, a trade group, and executive chairman of LifeMasters, a leading disease-management company, says that the congressional report does not reflect the most recent studies showing the clear cost benefits of disease management. Today, studies will be presented at the group's annual meeting in Orlando that show cost savings from 10 different diabetes-management programs and 11 asthma programs.

Cigna Corp., the big insurer, also says disease-management is cost-effective. A study in the most recent edition of Health Affairs of diabetic patients in Cigna health-care plans showed that the quality of care was higher and the overall cost of care significantly lower in plans with disease-management programs than in those without such programs. Indeed, Cigna saved more than it spent.

"These programs have a profound impact on the quality of care and costs on a short- to intermediate-term basis," says Allen Woolf, Cigna's national medical director. While it may not be clear if over the duration of a patient's life the programs decrease costs, for commercial insurers who may cover any given employee for five to seven years, "in those frames our data and the medical literature provide very strong support for offering these programs."

Robert Stone, executive vice president of disease-management firm American Healthways, which runs Cigna's programs, says that in addition to reducing costs for sicker patients, "if you get the newly diagnosed and healthier patients in the programs and help them stay in relatively good health, you can reduce later costs." Large employers are renewing their disease-management contracts because they see clear savings, he adds.

David Cutler, a professor of economics at Harvard University, says it's important to factor in benefits the CBO report didn't consider, such as increased productivity and fewer absences from work. But even if disease management is at best a break-even proposition, "from the societal level, comprehensive disease-management programs are clearly worth the investment," says Mr. Cutler. "What we care about is being healthy and having a higher quality of life, and if we can get there at no net long-term cost, that is undoubtedly a good thing."

E-mail Informedpatient@wsj.com

URL for this article (subscription required):
http://online.wsj.com/article/SB109822237688649826.html

The Business of Diabetes: Lilly Presents An Otimistic 2008 Forecast; Wall Street Less Certain

Yesterday at an investor conference, Eli Lilly and Company (the maker of the insulin analog Humalog, antidepressant Cymbalta, erectile dysfunction treatment Cialis and co-marketer of the type 2 diabetes drug Byetta) executives projected 2008 earnings per share between $3.85 and $4 on sales growth in the mid-to-high single digits.

According to analysts surveyed by Thomson Financial as well as Reuters' estimates, that forecast translates to growth of 8% to 14% over the expected 2007 full-year earnings, which exceeds analysts' 2008 profit forecast of $3.81 a share.

Recently, the company has tried its best to put a positive spin on the results for its anti blood clotting drug prasugrel, which, assuming it receives FDA approval, will compete with the blockbuster Plavix, which is jointly marketed by Bristol-Myers Squibb and Sanofi Aventis. But news that the company was halting a trial due to patient safety concerns raised questions about whether this drug would be a sure-fire blockbuster in the making, or whether the company was simply engaging in damage control.

As I wrote fairly recently, CEO Sidney Taurel wrote a scathing letter published in The Wall Street Journal about integrity in the media, but the irony was that his letter sounded, at beast hippocritical, more like a CEO who wanted to protect the value of his stock options than a company truly concerned about patient well-bring. With the company's latest forecast, the real question is whether anyone on Wall Street believes it.

"Clearly the 2008 forecast is much better than expected," said Lehman Brothers analyst Tony Butler.

A fair number of prominent Wall Street analysts have questioned whether the company will have enough new products to make up for the expected plunge in sales of several drugs that will lose their American patent protection in coming years. These drugs include the chemotherapy agent Gemzar in 2010, Zyprexa in 2011 and Cymbalta in 2013.

Citigroup Smith Barney noted "Lilly is including a timely approval of prasugrel in its assumptions, which could prove to be optimistic given the mixed TRITON study results. That said, even excluding a prasugrel launch, the guidance was above our expectations." This opinion was shared by many, including the few who remain bullish on the stock.

S&P said "we think long-term prospects hinge heavily on prasugrel, which has shown mixed clinical data (good efficacy, but with bleeding risks), to offset a patent cliff in 2010-2013."

That time period is a huge concern to analysts. Morgan Stanley analyst Jami Rubin echoed that outlook, saying "The issue is not 2008; the issue is 2011 and beyond."

Overall, Wall Street is presently evenly split when it comes to its outlook for Lilly. Zacks data shows that Lilly has earned 4 "strong buy," 11 "hold," and 3 "strong sell" ratings. This configuration leaves the shares vulnerable to both upgrades and downgrades.

Smith Barney, which is recommending its clients "hold" the stock, rated Lilly as Medium Risk, largely because of challenges to its in-line product portfolio (specifically Zyprexa, the insulin franchise, and Evista). They note that there are a number of downside risks to their target price.

Lilly was quite bullish on the outlook for its diabetes business, but a closer look suggests that outlook is not due to excellent fundamentals in the business, but due to some good luck. For one thing, the diabetes market is growing rapidly on a worldwide basis, so almost everyone will show some growth, even if they do nothing. But Lilly's diabetes drug outlook is heavily dependent on foreign sales, and it may be relatively easy to accomplish revenue growth in spite of severe weakness in its product line thanks to expected continued weakness in the U.S. dollar.

Drugs sold in other countries are paid for in the local currency while Lilly's costs are indexed to the dollar, so they benefit by converting those Canadian Dollars, Japanese Yen or Euros into U.S. Dollars. But the fundamentals look less solid.

In the U.S., Lilly's insulin business is likely to continue struggling. As The Wall Street Journal's Health Blog recently reported, the rivalry between Novo and Lilly means that while many drug sales reps are getting pink slips, both companies have instead been beefing their salesforces for diabetes products, although as The Wall Street Journal reported, Lilly has been using contract sales representatives rather than its own employees to sell its diabetes drugs. However, the other side to the currency exchange equation is that rival Novo Nordisk can hire more American salespeople while having a much smaller impact on its bottom line because their earnings are expressed in Danish Krones. It will be tougher for Lilly to absorb those costs, so it was not at all surprising that Lilly president John Lechleiter said that the company had no plans at the moment to hire even more diabetes reps, saying "We're not in this to see who can add more salespeople."

But Lilly also faces trouble from another European rival, France's Sanofi Aventis. Their rapid-acting insulin analog, Apidra (which is a relative newcomer), is very likely to take some share from both Humalog and Novolog because those are the two best sellers, and Apidra's market share is likely to continue growing, admittedly from a small base.

Finally, although the brand-name drug industry was able to postpone a vote on a bill in 2007 impacting biopharmaceuticals, it seems almost certain that in 2008, Congress will pass legislation enabling generic biopharmaceuticals (see here for my article on that subject, including links to many follow-ups). Even Novo Nordisk's U.S. President, Martin Soeters, told Reuters that his company fully expects generics to emerge by 2008 or 2009 at the latest. That means Lilly's venerable yet highly profitable Humulin business could face serious risks from generics in the not-too-distant future, and Humulin still accounts for about 25% of the company's diabetes business revenues.

The real question is whether Lilly's drug pipeline is all that much stronger than its rivals. In the words of The Wall Street Journal, at the moment "Big Pharma Faces Grim Prognosis". The rise of generics wouldn't matter quite as much if the drug companies research labs were creating a stream of new hits, but they aren't. Wall Street analysts examine the drug pipeline's thoroughly when making their forecasts, as do money managers such as pension funds and mutual fund companies who own the stocks.

On Friday morning, following the Lilly investor presentation, Lilly shares were little changed despite the company's rosy 2008 forecast. It seems that so far, investors remain unconvinced.

Arthur Frommer on Blogging

Contrary to the impression that I give with my blog, I do have a full life outside of diabetes, its just that has never been the focus of my blog postings. After all, I don't think people read here for details on how I spent my weekend (at least I hope not)! But every once and a while, I have some personal detail that is worth sharing.

On Tuesday night, I had the opportunity to meet Arthur Frommer, whose name is synonymous with travel since he first published his groundbreaking book "Europe on $5 a Day" back in the 1950's. He was giving a presentation to NYU alumni, although it was open to anyone who wanted to attend. Mr. Frommer has been hailed as "the dean of budget travel", and unlike the authors of some other travel book series, he actually stays at the lodgings that are recommended in his publications. The "Dollar A Day" series has since been retired, and in its place, a new series bearing the name of his daughter (Pauline Frommer) has emerged. Pauline, who co-authored The New World of Travel with her father, has authored a number of the books herself, and edited the ones she hasn't written personally.

I have long admired Mr. Frommer's work (although I preferred the books he personally authored much moreso than those done under the "Frommer's" brand name but written by others), particularly because I share so many of his views on the world. Self-described as "A devout liberal Democrat in the FDR tradition" he refuses to visit countries under occupation or military rule. Thats one reason some countries he once recommended, like Venezuela (which could re-emerge given this week's election results) and Thailand, have since been excluded from his recommended places to visit. He is also very opinionated, and occasionally, brutally frank about it -- one reason I like him as a travel writer! For example, Arthur Frommer's Branson, a travel guide he assigned to and wrote himself because of his Missouri boyhood. While he initially thought he would enjoy writing a book that celebrated the city's enterprise, instead, he was disappointed by what he saw, which was reflected (to some extent, anyway) in the book. Here's what he told the press about his Branson experience:

"I hated the jingoism. I hated these country singers, who had all been draft dodgers themselves during Vietnam, who marched down the aisle with drum beats, with machine-gun bullets, and waved the flag," he says, still disgusted. "Also, all of these people who became so religious! ... Many of the country-music theaters in Branson are used as stages for proselytizing." (Editor note: Gospel concerts are not necessarily the same as country concerts.)

Not everyone shares his political outlook or his perspective, but that doesn't mean they won't find his books valuable. In his own words, "Travel is scarcely worth the effort unless it is associated with people, learning and ideas." With the exception of The New World of Travel, Frommer's books generally stick to the basics, how to get there, get around, where to stay, where to eat, what the attractions are, etc., and those are usually routine without having an injection of too much personal opinion.

So, my readers may be wondering, what does this have to do with diabetes? The answer is nothing, but it does have to do with blogging, thus the reason I am sharing it today.

Arthur Frommer On Blogging

I asked Mr. Frommer to autograph my copy of The New World of Travel, which I consider to be one of his best publications ever. He naturally obliged, and when doing so, he commented "Gee, we really need to update this book" (the latest edition was last updated in 1996-1997), as he noted, some of the operators noted in the book had moved, been acquired, gone out of business, etc., although he acknowledged that the basic idea behind the book had changed very little, and that much remained as valid today as they did back when the book was first published in 1988.

I responded by noting, "There's always your blog!" He laughed, and said "I have really created a monster with the blog!", noting that he often feels compelled to make much more than 2 posts a day. (In fact, it is not uncommon for there to be 5 more more posts each day. Although not all are authored by him, those that bear his name are, and generally outnumber those that do not.) He mentioned that last year, there were over 800 postings in his blog. I said that no one expected him to have more than 1 posting a day, which he responded to by laughing.

Although I met him personally for only a few minutes, the time I did spend was quite valuable, and many of my questions were answered before I even asked them. In all, it was a valuable meeting.

Carb Management Good for Everyone, FDA Budget & Organization Issues

First, people with diabetes are regularly told that they should try to manage their consumption of carbohydrates, particularly highly-refined carbs like sugar, refined white flour, potatoes, rice and other foods that cause a rapid rise in blood glucose levels. The reasons differ, depending on what type of diabetes a person has. In the case of type 1, the non-physiological manner in which insulin is administered means that insulin is delayed in getting into the bloodstream and therefore cannot adequately match the body's needs. Although insulin analogs are supposed to better address this issue, they are not without their flaws. People with type 2 who use supplemental insulins have similar issues to people with type 1. They, along with those on other treatments also try to manage their carb intake to avoid spikes so the insulin already present in their bodies can work effectively with any other treatments they are using. Based on decades of experience, I certainly would never dispute the recommendation to manage carb consumption, because it has proven its value repeatedly.

However, I always have a sense of irritation when people without diabetes feel free to consume entire bagels (which are carb bombs, for a lack of a better term), and then wash it down with a sugary carton of orange (or grapefruit, apple, etc.) or a mocha frappucino and believe they don't have to worry about it because they don't have diabetes. It turns out that managing carb consumption applies to everyone, not just people with diabetes.

Whenever simple carbs are consumed, the body is forced to respond by releasing a surge of insulin to counteract the rapid rise in blood glucose caused by those foods. As a wise person once wrote (and I paraphrase here because I cannot find the original work), rapidly forcing glucose into the cells goes against the body's natural order of things, and this applies whether or not a person has diabetes. Many people without diabetes have reactive hypoglycemia caused by the insulin surge that the carb consumption causes. This may create a temporary sense of discomfort, but should also be a warning sign that what they're doing is not the best thing for their body or health.

Now, Researchers led by Chung-Jung Chiu and Allen Taylor, both at the Jean Mayer USDA Human Nutrition Research Center on Aging (HNRCA) in Boston, MA analyzed dietary intake and other data from more than 4,000 men and women aged 55 to 80 participating in the Age-Related Eye Disease Study, or AREDS. They found that consuming higher-than-average amounts of carbohydrates that cause blood sugar levels to spike and fall rapidly may be a risk factor for central vision loss with aging, which has nothing to do with diabetes, but does have to do with vision loss in the elderly. Although the findings are preliminary, they do suggest that the modern diet simply doesn't work as well as more traditional diets based largely on unprocessed foods.

See here for a summary of those findings: http://www.sciencedaily.com/releases/2007/11/071126153729.htm

Advisers Say F.D.A.'s Flaws Put Lives at Risk

Second, and perhaps more important, as the major news media reported, the U.S. Food and Drug Administration (FDA) is desperately short of money and poorly organized, which is putting people's lives at risk. The report was written by three members of the F.D.A. Science Board, an advisory panel that reports directly to the agency's commissioner, Dr. Andrew C. von Eschenbach. The three authors in turn had 30 scientific advisers.

Among the problems cited in the report were inadequate staffing, poor retention, out-of-date technology and a lack of resources, all of which have impaired the FDA's abilities. The report was a result of a year-long review by a distinguished panel of experts, the Subcommittee's report concludes that the state of FDA's scientific and regulatory programs could not be separated from the lack of resources available to support the agency's scientific base, hire and train a broadly-capable scientific workforce, and build a sophisticated and modern information technology infrastructure.

The full report, entitled "FDA Science and Mission at Risk", can be found at the Food and Drug Administration's website.

"Over the last decade, complex scientific advances, globalization and challenging new safety issues have combined to multiply the responsibilities of the FDA. As this new report makes clear: our expectations cannot exceed the resources we give FDA to accomplish its mission. In this regard, more is definitely better," commented Mark McClellan, MD, former FDA commissioner and chairman of the new Reagan-Udall Institute designed to enhance FDA's readiness for future scientific challenges.

But while Congress passed more than 100 laws expanding the FDA's authority since 1988, it has not increased the funding appropriately, the report found. As The New York Times reported, "the report concludes that over the last two decades, the agency's public health responsibilities have soared while its appropriations have barely budged. The result is that the FDA is falling farther and farther behind in carrying out its responsibilities and understanding the science it needs to do its many jobs." In fact, during the same 20-year period, while faced with 123 new statutes, FDA gained through appropriation only 646 employees - an increase of 9% - and lost more than $300 million to inflation.

To give just one example of how the agency's computer system has failed the public health, the report notes that "most recently during an E. coli food contamination investigation" the agency's aging computer system was prone to breakdowns.

"Reports of product dangers are not rapidly compared and analyzed, inspectors' reports are still handwritten and slow to work their way through the compliance system, and the system for managing imported products cannot communicate with customs and other government systems," the report stated.

In addition, the FDA often misses significant product arrivals because its computers are so poor that they cannot distinguish between shipments of road salt and those of table salt, the report said.

Don Kennedy, PhD, former FDA commissioner and editor-in-chief of the scientific journal Science said that the "FDA can't improve its science, prepare for the future, or protect American consumers without significant additional resources. Congress is negotiating FDA's FY 2008 (current year) budget right now and can start to fix this critical problem."

The current problem is caused, in part, by the major funding mechanism for the FDA at the present time. As the Boston Globe reported:

In 1992, Congress put the fox in the chicken coop. It passed the Prescription Drug User Fee Act, which authorizes drug companies to pay "user fees" to the FDA for each brand-name drug considered for approval. Nearly all of the money generated by these fees has been earmarked to speed up the approval process.

In effect, the user fee act put the FDA on the payroll of the industry it regulates. Last year, the fees came to about $300 million, which the companies recoup many times over by getting their drugs to market faster.

But while it's a small investment for drug companies, it's a lot of money for the agency, and it has drastically changed the way it operates -- creating a disproportionate emphasis on approving brand-name drugs in a hurry. Consequently, the part of the agency that reviews new drugs gets more than half its money from user fees, and it has grown rapidly. Meanwhile, the parts that monitor safety, ensure manufacturing standards, and check ads for accuracy have languished or even shrunk.

Obviously, the President and Congress shares the blame for this situation, but it remains to be seen as to how they address it. The user fee system has enabled the U.S. Government to largely avoid paying for the agency which is responsible for the safety of the U.S. food and drug supply. With their focus fixated on a failed policy in Iraq and a desire to cut taxes (for certain groups, anyway), Congress had planned to simply re-authorize the user-fee system and the President promised to rubber-stamp approve it as long as restrictions on the Pentagon's budget were not included.

But the moral to the story is that if we want the food and drug supply to be safe, then taxpayers need to pay for it, otherwise we have no one to blame but ourselves. Perhaps this report will help change some minds among lawmakers.

No Dumb Diabetes Research Awards for 2007

In the past around this time of year, I had people vote for the "Dumbest Diabetes Research of the Year". I will not be doing that in 2007, in part, because I did not do much as far as tracking the mindless studies done in the name of diabetes research this year. I must apologize if anyone was hoping to vote, but I would have to spend a lot of time sifting through medical journals, and at this time of year, that really isn't my priority right now. But I'd love to collect your nominations!

As you may recall, last year, the winning study was an article entitled "Short legs related to excess weight and diabetes" in which researchers from Johns Hopkins University conducted a cross-sectional analysis of 7,424 adults aged 40–74 years, from the third National Health and Nutrition Examination Survey (NHANES) and concluded that being short - specifically having short legs and a low leg length-to-height ratio - was linked to an increased type 2 diabetes and obesity risk in middle age. They recommended "early intervention" to improve childhood nutrition in diabetes prevention. While this was a meta analysis, the study suggested that the parents are to blame for adults getting type 2 diabetes, which may be a flawed conclusion. Other studies examined, if you can believe it, the effect of chili consumption on glycemic control. Gimme a break!

Each year, including 2007, millions of dollars are indeed wasted on such mindless research, rather than investigating flaws in current treatments, or looking at issues that are important to patients. As my post last week noted, most studies undertaken ignore everything but glycemic control, and an article published in The Lancet calls into question whether the medical profession needs to re-examine the issues that clinical trials actually investigate, because there is more to managing diabetes than simply controlling blood sugars, its just that researchers seem blinded to that fact.

More troubling is the not-so-subtle implication that results from a non-scientific sample are applicable to all patients with diabetes, which is not only inappropriate, but helps perpetuate myths about diabetes to an already ignorant population.

Last week, Reuters did a story with a headline declaring that people with diabetes routinely make unsafe driving decisions, specifically claiming that patients drive automobiles while their blood glucose levels are hypoglycemic.

Unfortunately, the study, which was done in the Netherlands, was conducted on just 65 people, and the number of people who behaved in the risky manner was a mere 21 people, which is hardly sufficient to declare millions of people worldwide (including many with type 2 who are less prone to hypoglycemia because they have fully functional counterregulatory systems, which are impaired in people with type 1) as routinely engaging in unsafe behavior. Yet the headlines suggest guilt by association. Lilly's Sidney Taurel may gripe about the media not being objective in its coverage, and this may not be exactly what he had in mind, but there is some truth to that assertion.

Regardless, I would encourage everyone to read the details before succumbing to the media's declarations that damn the entire Diabetes OC Community, whether it is engaging in risky driving behavior, or of having a "lifestyle" disease caused, according to the media's description, by sloth.

Mr. Taurel is right that the media needs to do better, but not just to benefit Eli Lilly and Company shareholders, but to ensure people are not given sound bytes of mis-information about diabetes.

Most Diabetes Clinical Trials Ignore Everything But Blood Sugar Control

For those of you who read Diabetes Health, you may have caught a recent write-up that indicated a commentary article published in the September 29, 2007 edition of The Lancet entitled "Patient-important outcomes in diabetes—time for consensus" in which the authors, largely from the Mayo Clinic, report that a majority of diabetes clinical trials in the U.S. ignore virtually everything except glycemic control. In the article, the authors wrote:

"Unfortunately, HbA1c loses its validity as a surrogate marker when patients have a constellation of metabolic abnormalities, when the most common complications are macrovascular, and when the treatments have multiple poorly understood effects."

Obviously, that was a not-so-subtle reference recent issues with the GlaxoSmithKline drug Avandia. Unfortunately, the reason for this is driven largely by the U.S. Food and Drug Administration (FDA) and other drug regulatory agencies, which really consider nothing else except glycemic control when evaluating new diabetes treatments. But the same applies to type 1 diabetes treatments, too.

For example, Dr. Steven Edelman, assistant professor of medicine at the University of California San Diego School of Medicine, wrote to the FDA in 2003 in support of Symlin's New Drug Application, "Our country has tunnel vision in that a drug is judged on its ability to drop the A1c and is blinded to the many other important aspects that a therapeutic agent for diabetes can offer."

Even if a patient's A1c doesn't shift, most diabetes medicines (including insulin) still have major problems that impact patients' overall quality of life as well as compliance, including unpredictable glucose swings throughout the day, hypoglycemia, weight gain, gastrointestinal issues, and general frustration with the lack of precision in trying to actually control their blood glucose levels.

At least now we have credible, peer-reviewed data to quantify just how widespread this problem actually is, which happened to be published in the world's oldest peer-reviewed medical journal. According to the Mayo Clinic, only 1 in 5 trials measures the effect of drugs on quality of life and risk of complications. As Diabetes Health summarized, "The trials can be smaller, shorter, and cheaper without considering these factors, but they're not necessarily better for patients."

According to the commentary by Victor Montori, MD, of the Mayo Clinic, "the apparent benefits of these trials are a mirage….Patients and society may end up paying dearly for medications that cause more harm than good…. The medical community should insist that we invest the resources needed to do trials that ascertain the effect of interventions on patient-important outcomes."

The commentary concluded: "A conscientious patient with diabetes would like to choose drugs that maximize benefit (reduce complications) and minimize burden (route of administration, need for self-monitoring, cost), side-effects (weight gain), and efficacy failure (hypoglycemia)."

I happened to find a copy of The Lancet article on the Internet (normally, they charge $30) so you may access the Lancet commentary, including a truly lovely photograph of a foot ulcer here. Happy reading!

Note to Sidney Taurel: Don't Expect Us to Cry You a River

This morning's Wall Street Journal featured an interesting opinion piece written by Sidney Taurel, who is the chairman and CEO of Eli Lilly and Company. See below for details. My previous letter written to him can be seen here.

In his commentary, Mr. Taurel argues that a lot of pharma reporting in the media is misinformation, or perhaps what could best be called sensationalism. While I agree with that general assessment, Mr. Taurel may find the reasons for my agreement a bit more disturbing.

First, lets look at the big picture. Since 1997, when the Food and Drug Administration (FDA) loosened the restrictions on what is called direct-to-consumer (DTC) advertising, drug companies have spent billions of dollars advertising their drugs to a general audience. Amy Tenderich recently wrote "direct-to-consumer (DTC) advertising 'glamorizes and normalizes the use of prescription medication.'"

Apparently, what Mr. Taurel refers to as "the media beast" which he claims needs to be fed copy, is not above using the media, or even manipulating the media to push drugs like Cialis for erectile dysfunction (have you seen any Cialis commercials when watching the NFL lately?). Lilly is hardly alone in this, so they can't really be singled out for the practice -- its arguably necessary to compete in this segment.

To be completely fair, consumers aren't stupid, and they are easily able to distinguish paid advertisements from other media programming. But more subtle manipulation of the media is also apparently fair game, and Lilly is a master of that. But isn't complaining about the same media you feel completely free to manipulate to your company's benefit a tad hypocritical? Like anything, you cannot have the good without also having the bad, otherwise those two terms have no meaning whatsoever.

But I am more troubled by what seems to be a bit of bitterness by Mr. Taurel when the company's stock price is suddenly hit, then all of a suddenly company is concerned about truth in media. Perhaps Mr. Taurel is getting ready to retire and the value of his stock options fell as a result of the latest incident.

But as a Lilly shareholder, I feel company management has violated their fiduciary responsibility to us, and that does not make me happy. The insulin business has been ignored for over a decade, and market share trends reflect that. In 2000, the company had 82% of the U.S. market, while in 2006, they had just 43% according to data from IMS Health. This was done as the company poured billions of dollars into treatments for such urgent medical conditions as male impotence while investing hardly anything in the company's area of traditional expertise: type 1 diabetes treatments.

The following is an excerpt from Dr. Arthur Teuscher's recent book (see Forward, p. VII), "Insulin: A Voice For Choice" (also see the Diabetes Health article on it here):



On October 29, 1982, the United States Food and Drug Administration (FDA) approved an application by Eli Lilly and Company of Indianapolis, Ind. to market its new synthesized recombinant DNA insulin. The FDA's 4-month review of this first medical product of biotechnology was remarkably less than the average time for drug reviews in those days, suggesting unusual enthusiasm by the FDA staff for the product. The product's name, also subject to FDA approval, was 'Humulin', a name which contradicted the agency's long-standing regulation disallowing "fanciful"' names or false and/or misleading claims embedded in the name. (As the footnotes indicate, "An example of an intervention by the FDA was its ruling that an oral contraceptive marketed as 'Marvelon' in many countries could not carry this name in the U.S. since it suggested that the drug was 'marvelous'. Similarly, 'Humulin' suggests that the product is human insulin, which is a false claim. More recently, the FDA rejected the name Acomplia (rimonabant), Sanofi Aventis' potential anti-obesity drug because the name would imply that the drug helps patients accomplish weight-loss, and it was felt that was misleading.)

The marketing of Humulin suggests that the product is human insulin, which is a false claim. Nevertheless, manufacturers re-enforced this misapprehension with a sophisticated and aggressive marketing strategy based, in part, on the premise that 'human' insulin is identical to insulin produced by nondiabetics and therefore must be safer and more effective than insulin obtained from animals. Thousands of physicians, targeted by drug company sales representatives, have internalized that message and have repeated it to their patients. You should be ashamed of your abuse of the media, Mr. Taurel.



As the book notes, Humulin and other synthetic insulins marketed by other companies are by no means identical to natural human insulin as their names imply (for one thing, Humulin is not produced by pancreatic beta cells, and it is missing several elements which found in natural insulins, including the beneficial C-Peptide). And an estimated 10% of all patients, particularly those who began treatment with animal-sourced insulins, have severe hypoglycemia unawareness that is a direct result of synthetic insulin (remember that type 1 diabetes is caused, in part, by an allergy to human insulin, so this is not so surprising in light of this fact).

The bigger issue is that while we all agree that the media's reporting is often lacking, one cannot manipulate that media on one hand while complaining about it on the other. None of us should buy that Lilly's overriding concern is patients. It isn't, otherwise the company would not be withdrawing insulin formulations that patients relied upon to force them to use more profitable new products. Don't expect us, as Lilly customers to agree with your manipulation of the media, nor as Lilly shareholders to justify your complaints.


Commentary: The Media on Drugs
By Sidney Taurel, published in The Wall Street Journal
November 27, 2007; Page A19

When it comes to describing the benefits and risks of prescription drugs, the hyper-competitive, around-the-clock media is rarely at its best. Call the following a case study in the challenge of doing right by doctors and patients -- in spite of the need to feed the media beast with copy.

Our story starts Oct. 24, when several media outlets reported that Eli Lilly and Company had halted two clinical trials for the drug prasugrel -- a possible new therapy for heart-attack patients that Lilly is developing with Daiichi Sankyo. The speculation that followed these reports was that the drug must have failed its initial trials. Within a few days the market capitalization of Eli Lilly fell by about $6 billion.

This speculation was unfounded and, incidentally, false. In early November, the academic TIMI Study Group announced the results of a massive clinical trial showing that prasugrel produced significant improvements in patient outcomes compared with current treatments.

Specifically, the trial, known as TRITON, showed that prasugrel produced a 19% reduction in relative risk for cardiovascular death, nonfatal heart attack, or nonfatal stroke when compared with the drug clopidogrel -- today's standard of care -- and had a favorable benefit-risk profile in a large majority of patients.

Statistical data can be interpreted in different ways. Some experts will reach more nuanced or skeptical conclusions about TRITON. But a Duke University cardiologist told this newspaper, after seeing the trial's results, "If you can't get a drug on the market with that kind of data, we should stop developing drugs."

So what happened in those days after Oct. 24? Lilly's goal was to turn over our prasugrel findings to doctors in a manner that left no doubt as to their scientific rigor and completeness. This meant publishing the findings in a highly respected journal and discussing them directly with top cardiologists, ahead of mass-media reporting. We decided to present these findings to the New England Journal of Medicine (NEJM) and the Annual Scientific Sessions of the American Heart Association (AHA) on Nov. 4.

NEJM and AHA asked for promises from Lilly and its partners, and we agreed, not to disclose any of the results of TRITON prior to Nov. 4. Such guarantees of exclusivity are not only common, but also appropriate, in focusing expert attention on important research. A definitive source and a "zero hour" of first-hand disclosure for complex scientific data help to limit misinformation.

Doctors and scientists at Lilly and Daiichi Sankyo, of course, had begun to analyze the results of TRITON in the weeks leading up to the AHA meeting. In addition to showing strong efficacy, the data also showed that in three small subgroups of patients, the drug at its current dosage raised the risk of major bleeding relative to its effect on preventing heart attacks.

Lilly had two small clinical trials of prasugrel underway for different research purposes, and we had received no reports of safety concerns from them. But when we saw the TRITON results, we put patients first. Based on the small chance that patients in the three identified subgroups might be given prasugrel and experience serious bleeding, we advised our researchers to suspend the two trials pending a review.

Enter the beast. Ten days before our "zero hour," word leaked out, causing us to confirm that the two prasugrel trials had been suspended, although our promises to NEJM and AHA prevented us from explaining why. The media entered a feeding frenzy, catered by commentators on Wall Street and elsewhere who speculated that prasugrel posed broad risks and had probably failed its major trial. Our stock began its trip south and, more seriously, some doctors and patients were left with false impressions.

Unveiling the data at AHA brought some relief. Still swimming against the tide of rumor, a few stories distorted the TRITON results, but most were balanced. In the end, the Food and Drug Administration will not rely on media reports to reach approval decisions. Lilly is confident that prasugrel will be given a chance to help patients on a large scale.

There are a few lessons here that need to be learned. For the pharmaceutical industry: Preserving the integrity of scientific data and protecting the safety of patients are always the right choices. Stock prices recover but trust is much harder to regain. Trust hinges on our openness in sharing everything we know about who should use our products -- along with when, how and at what dose -- and who should not.

For the media, if I may be so bold: Don't trade in leaks and rumors where scientific data are concerned. Damage to public understanding is hard to repair after it's been done. Wait for real numbers, and take the time to explain statistics and benefit-risk analysis, which cannot be conveyed in sound bites alone. And for would-be pundits: If you have not had firsthand exposure to the scientific results or specialized knowledge under discussion, then qualify your comments if you must make them at all.

We all have a stake in taming this beast -- not for the sake of any company or individual discovery, but for the sake of those who ultimately rely on accurate information for the care of patients.

Mr. Taurel is chairman and CEO of Eli Lilly and Company.

Indiana State Police Searching for 2 Truckloads of Stolen Insulin

This weekend, the media in Indiana reported that Indiana State Police were investigating a theft involving two truckloads of stolen insulin, undoubtedly from manufacturer Eli Lilly and Company, which manufactures most of the insulin sold in the U.S. in the company's Indiana facilities (although the company also has a substantial manufacturing operation in Puerto Rico, mostly for the insulin analog Humalog).

Reports indicated that the stolen trucks contained health and beauty aids and 21 skids of insulin stored in the refrigerated trailers, which were stolen from a Plainfield, IN trucking company between 11:45 p.m. Wednesday and 10:45 a.m. Thursday.

Indiana State Troopers continued Friday to try to determine how and why the trailers were stolen. An increase in truck traffic has occurred in the Plainfield area along with construction of several warehouses near I-70 and the Indianapolis International Airport.

One of the stolen trailers is a 2004 Utility, and the other is a 2006 Great Dane, according to the news release. The trailers' only distinguishing characteristics are their red axles and wheel hubs, troopers said.

The relevant trailers were stolen from Daum Trucking, along Indiana Route 267 just north of U.S. 40. The trailers were not painted with any company logo and had stainless-steel sides, State Police said. Other reports indicated that the license plate of the 2004 Utility trailer was Indiana 614231, and its VIN number is 1UYVS25384M157905. The plate of the Great Dane trailer is Indiana 609868, and its VIN number is 1GRAA062X6W705555. The two trailers could be worth more than $1 million.

Sgt. Rich Myers of the Indiana State Police said the thieves must have known what was in the trailers. Myers also says that by not maintaining the medicine properly, the thieves could be selling a toxic product.

"If this insulin is not maintained at a proper temperature, it can go bad, and if someone does take this insulin it can cause very bad sickness and even death."

At this time of year, the biggest concern is not excessive heat (which is also damaging), rather, freezing of the insulin. Either way, failure to maintain the temperature could put patients at risk.

Indiana State Police urged anyone who is offered insulin from other than normal medical and retail suppliers to contact the Indiana State Police or the nearest law enforcement authority to report the circumstances of how the insulin was offered. They can reach them at: (765) 653-4114. The toll-free number is: (800) 225-8576.


News Sources:
http://www.indystar.com/apps/pbcs.dll/article?AID=/20071123/LOCAL/71123021

http://www.indystar.com/apps/pbcs.dll/article?AID=/20071124/LOCAL/711240476/-1/LOCAL17

http://www.wishtv.com/Global/story.asp?S=7400876&nav=0Ra7