Most of what I’ve read and previously written about electronic health records has been about making them work better or getting more clinicians to use them. Security of patients’ on-line data hasn’t been a major topic of concern. I’ve assumed that this was because these concerns had mostly been addressed back in the late 1990s during the development of the Health Insurance Portability and Accountability Act (HIPAA), or because those creating systems to allow medical information to be internet accessible – like those coalitions building dedicated Health Information Exchanges and companies like Microsoft, Google, and BlueCross BlueShield insurance plans – have resolved the security concerns.

Global Cyber-Security
However, I just read the cover story in the May 31st National Journal (”China’s Cyber-Militia”), which made me question these assumptions. The article doesn’t mention healthcare or electronic medical records, but it makes me very concerned because it discusses how Chinese hackers (or hackers working through computers based in China) have been responsible for serious industrial/utility computer breeches, and how government and private sector officials at the highest level are very concerned about this and the trend towards even more cyber-infiltrations.

If I had heard this third-hand I’d be inclined to dismiss it as extremist or Luddite hysterics. But the National Journal is solidly in the mainstream of responsible journalism, and even when their article cites reports from other publications (such as the New Yorker) they reinforce the point with information from other sources and direct interviews with knowledgeable insiders.

Some of the specific points in the article that made me sit up and take notice were:

The February, 2008 blackout affecting 3 million people in South Florida was probably caused by “a Chinese PLA [People’s Liberation Army] hacker attempting to map Florida Power and Light’s computer infrastructure apparently made a mistake. “The hacker was probably supposed to be mapping the system for his bosses and just got carried away and had a ‘what happens if I pull on this’ moment.” The hacker triggered a cascade effect, shutting down large portions of the Florida power grid, the security expert said. “I suspect, as the system went down, the PLA hacker said something like, ‘Oops, my bad,’ in Chinese.”

The article also discusses how the massive August 2003 blackout in the Northeastern US is believed to have been due to Chinese hackers – despite the public explanation that it was caused by overgrown trees in Ohio hitting high voltage lines.

The article even delves into how Chinese hackers are infiltrating corporate computer systems to steal company technology and business secrets, plans and strategies. For example, it includes a security expert’s story about one company’s experience of entering into face-to-face business discussions in China where “the Chinese based their starting points for negotiations on the Americans’ end points.” As Joel Brenner, the US government’s chief counterintelligence officer is quoted in the article, “If you travel abroad and are the director of research or the chief executive of a large company, you’re a target.”

Security of Online Health Records
Two potential weaknesses of utility and corporate computer systems may be because their systems are from third party vendors or were built with older architecture designed before on-line security was a concern. Because the computer systems for electronic health records and information exchanges are being built by the companies who are using them or have ongoing contracts for maintaining them – and are probably being built with newer software architectures – perhaps they are better protected.

The other reason why online health records may be more secure than utility or corporate systems is that hackers probably don’t have the financial or geopolitical incentives to break into medical record depositories. However, I can imagine situations or incentives for groups (aside from pure nihilism) that could change that – butI don’t want to speculate here and give anybody any ideas.

But if one of the great potential values of electronic medical records is having them joined together into Health Information Exchanges, and hackers are apparently able to infiltrate and wreak havoc in sophisticated computer networks, then I hope those developing EMR and HIE systems are really paying attention to security issues. If patients have concerns that their personal information is hackable, this could lead to a tremendous backlash against the use of a technology that should be very valuable for improving the quality of care and reducing the long-term growth in healthcare costs.

The FDA announced today that they have sent letters to 25 companies to stop selling fake cancer cures. That is, things that the companies claim cure cancer, but have never been tested, or approved by the FDA. The FDA has a web-site with more information about this, and a sub-page that lists 125 Fake Cancer Cures.

I know the FDA gets lots of flack for not doing enough - and not doing it fast enough - I applaud the FDA for taking this action, and encourage them to do more because I have found the advertisement and selling of these non-medicines troubling for a long time.

Cancers are serious diseases by anyones definition, and real medical science is making great strides in developing better treatments and cures, and in overall improving the lives of people living with cancer - both through traditional drugs and biologics, as well as with complementary therapies. But those profiting from selling fake medicines are selling false hope.

I would like the FDA go after more of these people who are profiting from selling fake medicines marketed as cures for other diseases and conditions - particularly ones that may be for symptoms of serious conditions. For example, every time I see the plastic-faced grinning guy on TV hawking a non-FDA approved “natural male enhancement” product, I wonder about all the men who may still be too embarrassed to talk to their physician about their erectile dysfunction problem - which unknown to them is being caused by a serious medical problem, like cancer. And of course for men who are buying this stuff who don’t have ED, then it would be nice if they could talk to their physician about therapy to address the route causes of their feelings of sexual inadequacy.

But of course, the FDA currently has insufficient resources to cover all of it’s multiple priorities - which is why Congress and the Administration are discussing how to provide more funding. Until that happens, I hope the FDA continues being vigilant and stops as many of these purveyors of false hope as they can - at least so these people don’t get the idea that because the FDA’s resources are stretched a bit thin, that the FDA won’t bother them.

Memorial Day weekend is the traditional start of summer. This weekend also brought me in touch with some other markers of time, including:

• A great celebration of life event for the passing of a friend’s father – a terrific gentle bear of a man who had faded away in recent years after more than four score years
• A double birthday party for the children of some friends – a 9 year old and a first birthday
• Senator Kennedy’s long tenure and track-record of accomplishments – which were chronicled in many news reports following his being diagnosed with a brain tumor

I was also reminded of the importance of planning over time by a recent op-ed that mentioned a national organization’s call for increasing medical school enrollment in order to avoid a future shortage of physicians. Since the time from the start of medical school to the end of clinical training is generally 7-10 years, this pipeline is similar to the process for developing drugs. Each require many years for the development process as well as for increasing output capacity – which are both limited by money and other resources (trained people, physical structures and equipment).

However, because increasing this output capacity takes time, it is important to invest in them before the need is there. Senator Kennedy has understood that for decades, as has been evident by his long support for biomedical research funding. We can only hope that it will provide substantial benefits to him in his latest fight. And if not, then the hope is that these investments will benefit the generation of the birthday celebrants from last weekend. I believe this will happen since decades ago cancer was seen as a dreaded diagnosis, but now for many patients, it is curable or manageable – just ask, John Lester, the Red Sox pitcher who went from cancer patient to pitching a no-hitter in less than 2 years. And the hope for the future is that if the family or friends of today’s nine year olds have to face cancer in several decades, they will be able to use one of their favorite words of today - “boring.” (“School is boring.” “The beach is boring.” “That’s boring.” “This is boring.”)

The promise of today’s research into cancer and other diseases is that over time, treatments will become boring. Boring is the best type of medical problem to have, because it indicates that it’s treatment is so routine, easy and palatable that both the physician and the patient have no anxiety about it.

Past research and development weren’t enough for my friend’s father – who had a terrific life and shared Senator Kennedy’s passion for sailing. Time will tell if the last few decades of research were enough to make Senator Kennedy’s treatment boring. As summertime comes and goes this year and next, here’s hoping that more and more of the medical problems we and our families see are boring. I think it is fitting that as Memorial Day 2008 passes, we recognize these events and promises of the future, and remember what has been, but also what can possibly be.

A few weeks ago I wrote about the challenges of adopting electronic medical records to provide value for different stakeholders and the entire health care system. Well, this week the Congressional Budget Office released a paper on “Evidence on the Costs and Benefits of Health Information Technology.” This paper is a reasonable review and synthesis of the literature, but it’s important to recognize that the CBO’s mission is to focus on how federal legislation can change government spending.

While the paper concludes that savings from adopting HIT are generally uncertain, it does make some supportive comments about its value. For example the paper states that “the net effect of more use of health IT would probably still be lower overall costs than would otherwise be the case.” Another perspective about the value of HIT systems in the CBO paper is that HIT systems have a fundamental role as an enabling tool for improving the performance of the health system by making it “easier to reduce health spending if other steps in the broader health care system are also taken to alter incentives to promote savings.” One specific way HIT systems do this is by promoting greater financial integration among payers and providers as they collaborative fund HIT systems because each will share in the benefit of the systems. (The paper also notes that by making more clinical information available in electronic form, HIT systems can help facilitate cost effectiveness research which can also lead to cost savings.)

In terms of Federal funding to support HIT use, the paper notes that, “Given that the returns of health IT to the providers who invest in such systems are less than the returns to society as a whole, an argument could be made that the federal government’s intervention is necessary to raise the rate of the technology’s adoption to be more in line with its total returns.” And, “Relying on private markets to act, however, would probably lead to a slower rate of adoption than if the federal government intervened.”

How then should the federal government promote greater use of HIT systems? Aside from the leading role the government has already taken is setting standards for many technical specifications of HIT systems, the CBO paper states that the three primary avenues are:

1. Mandating use of HIT system
2. Financial incentives to use HIT system
3. Grants to subsidize purchase of HIT systems
   

So while the CBO study is a good synopsis, it doesn’t really add much that is new: In looking for ways to control healthcare costs, health information systems are only one piece of the puzzle, but they are a crucial for improving the efficiency of healthcare delivery, avoiding preventable mistakes – like adverse reactions from known drug allergies– and helping people get better faster by not making them wait to be treated while tests are repeated.

What I conclude from all this is that investing in HIT systems is like encouraging preventive care and testing. Both have up front costs that produce future benefits, and both are only valuable when used appropriately. Perhaps if we relabeled HIT systems as a type of preventive health intervention, there would be more widespread public support, since everyone likes prevention - right?

What do you think?

Electronic medical records (EMRs) have been touted as one of the solutions for healthcare’s cost and quality problems. But why haven’t we seen more benefits from EMRs?

Disconnect Between Costs and Benefits
The simple answer is that there is a disconnect between those who have to pay for EMRs and those who benefit from them. For example, many (if not most) national health reform proposals call for investing billions of dollars in EMR systems claiming that EMRs will save the healthcare system lots of money. However, these savings projections hide many important factors related to the timing of any potential savings, and how different stakeholders would be affected. Three specific questions should be asked about investment for any new technology such as EMRs:

1. What are the direct and indirect costs and savings for the innovation?
2. What are the expected time-frames for each of these effects?
3. How do each of these effect different stakeholders?

For EMRs the answers to these questions are:

• There is a very large upfront costs for hardware, software, training, and converting paper records into an electronic format. Installation costs in outpatient settings have been estimated to be $40,000-50,000 per physician. In addition, clinical specialties that see patients more episodically (like surgeons), may find it easier to convert to EMRs than clinicians whose patients have chronic conditions (like diabetes) where it is important to have their long-term medical information in the EMR.
• EMRs can increase physicians’ billing revenue by enabling them to provide more accurate and complete information to payers, and thus get paid for more of the services they are actually providing and have fewer claims returned because of insufficient information. (Clinician’s increased revenues would also represent increased costs for payers.)
• EMRs ability to increase the efficiency of processing payments could reduce the staffing needs for clinicians and payers.
• EMRs can reduce the need for repeating tests when patient’s medical records cannot be found. This would result in savings for payers and patients, but might also result in lost income for the clinicians that provide those tests and related services.

The table below illustrates how each of these effects of EMRs falls into different types of costs and saving for different stakeholder groups:

Direct & Indirect Costs & Savings by Stakeholder Groups for EMR Adoption

One of the significant challenges of EMR systems is convincing people (particularly physicians and payers) that they will have real benefits that are worth the costs. Two articles have questioned the size and scope of benefits EMRs can produce: Linder et. al. in the Archives of Internal Medicine from July 2007 found that EMRs didn’t correlate with better quality indicators based upon a national survey of ambulatory care sites. The other was a April 2008 perspectives piece by Hartzband and Groopman in the New England Journal of Medicine. They noted that EMRs can “force doctors to give “standard” rather than “customized” care,” and concluded that, “We need to make this technology work for us, rather than allowing ourselves to work for it.”

Recent EMR Adoption Initiatives
Recognizing these potential pitfalls of EMRs, two recent initiatives to increase EMR use in doctors’ offices are taking different approaches – one in the State of Massachusetts and the other by Medicare:

The Massachusetts program is funded primarily by $50 million from Blue Cross and Blue Shield of Massachusetts to a non-profit third party organization (Massachusetts eHealth Collaborative) that is providing direct funding and technical assistance to three pilot areas in the state. The Massachusetts pilots are also being evaluated as they are implemented. (More about that below.)

In contrast, Medicare’s demonstration program will pay physician practices for installing EMR systems based upon the number of Medicare patient they see, and it also ties future year payments to reporting of quality information (year 2) and then being able to demonstrate actual quality improvements (years 3, 4, and 5). Medicare has called these additional requirements as “Pay for Reporting” for year 2, and “Pay for Performance” for years 3, 4, and 5.

The challenge for Medicare’s demonstrations is about money. With estimates of more than $40,000 per physicians for installation and training for a new EMR system, physicians may take a Missourian “show me” attitude – or maybe it’s more Jerry Maguire “show me the money” attitude. However, the Medicare demonstration projects are not guaranteed money and the payments are made retroactively. According to Medicare’s Acting Administrator in April:

“…the total potential payment over the five year course of the demonstration is up to $58,000 per physician, up to $290,000 per practice. And again the degree to which a practice scores on the Clinical Quality Measures and scores higher on the Office Systems Survey will determine the level of incentive that they get. Also I want to point out that, again, payments are retrospective and practices can, again, use the funds as they feel appropriate for their practice.”

Part of the reason Medicare is structuring it’s demonstration this way is because under Federal law it must be budget neutral so that the demonstration’s costs will be offset by savings to the Medicare program.

Before looking at how the value of EMRs are being evaluated, it is worth mentioning the EMR system used by the Veterans Administration’s health program. The VA’s VistA System is reported to be clinically useful , but it does not support billing which is a big problem for non-VA users. That is the primary reason why although the VistA system is free, it hasn’t been adopted by non-VA users.

Evaluating the Value of EMR Adoption
Massachusetts’ EMR initiative was started based upon the widespread belief that EMRs can produce overall clinical and economic value. However, as noted above, there have been some analytical and academic questions raised about this general premise. To demonstrate the clinical and economic effects of the EMR pilots in Massachusetts, their initiative has at least six components to evaluate the economic and clinical value by measuring both quantitative and qualitative outcomes. These are being rolled out in a logical fashion, and are summarized below:

Evaluations of Massachusetts EMR Pilot Projects

* HIE: Health Information Exchange – a system being implemented in coordination with the EMR pilots to enable physician offices to have access to all of a patients’ medical information from all clinicians within the community.
Source: Conversation with Micky Tripathi, President and CEO of Mass eHealth Collaborative, and Mass eHealth Collaborative Spring 2008 Newsletter

Conclusions: (Sorry about the very long posting)
Electronic medical records systems have the potential to improve quality and reduce costs, but there are significant barriers to their adoption by independent and small groups of physicians. The results of Massachusetts’ evaluations and the success (or “lessons learned”) of Medicare’s demonstration program will be important for guiding future Federal, State or private sector efforts to promote (or require) the use of EMRs in the US.

Any other thoughts about EMRs?

Several people have recently told me quality of care stories, and one nursing group sent me a list of 25 Tips to Help Protect Yourself from Medical Errors. The common theme for all these is that to help avoid errors, the patient (or their family) should make sure they are informed about their condition and treatments, and they need to develop relationship with clinicians that enable good communications.

The first case is a friend’s father who, after suffering a spinal cord injury, is living in a nursing home/rehabilitation facility. Cognitively he had been doing great - 80+ years old and did his own taxes this year.  Over the course of a couple of days he became much sleepier, stopped eating much, and just “wasn’t himself.” It was up to his wife, daughters and son to initiate prompt attention to his situation. Possibly because his son is an ER physician, this attention came sooner, and the good news is that after some not too complicated medical treatment, he is doing much better, eating, more awake/aware, and back to his regular self.

One of his daughter noted that the staff of the facility should have noticed the changes. But she also recognized that many of the other patients in the facility are much less engaging and alert than her father, so his changed alertness, etc. might not have seemed abnormal to them. She also noted that since many families don’t have physicians to directly raise questions, then similar problems might not be addressed as quickly as her father’s, and this could lead to bad outcomes. This ‘knowledgeable squeaky wheel gets the oil” is probably an unfortunate reality of our healthcare system – and probably other parts of our society as well.

The second situation was more systematic, and involved the possibility that some of the innovations we are looking for to improve the quality of care, are not without their own pitfalls. One example of this was brought to my attention by an old friend, and involved the use of computerized order entry systems (CPOE) in hospitals. These systems are becoming quite common (Massachusetts is in the midst of an initiative to install them in every hospital in the state), and have been shown to reduce medication errors from bad handwriting, and missed drug-drug interactions and allergies.

However, like many tools, CPOE systems can also breed their own sources of errors. My friend told me how such a system had resulted in one patient receiving a large overdose of narcotics. The problem that led to this occurring was systemic in that the CPOE system had enabled the large dose to be automatically ordered for the wrong patient, and because many patients on the floor were receiving large doses of narcotics the nurses did not perceive this as unusual. Fortunately, the situation was addressed and the patient was fine.

The overarching principle here is that quality of care is a great goal, but technology is only part of the solution. As Drs. Groopman and Hartzband concluded in their recent New England of Journal perspectives piece about electronic medical records (EMRs), “We need to make this technology work for us, rather than allowing ourselves to work for it.”

I completely agree with Groopman and Hartzband, and usually state this the principle more directly as, “Make the technology work for you, don’t work for the technology.” (I suspect that we both heard something like this first somewhere else.)

What are the most common or serious reasons for quality of care problems you’ve seen? And how often has patient-physician mis communications contributed to the problem?

For several years it has been clear that funding limitations are impairing the FDA’s ability to attract and retain qualified clinicians and scientists to review applications for new drugs and biologics, and to support their internal research and analysis concerning new drug development, manufacturing and monitoring technologies – particularly for biologic medicines. In addition, the FDA hasn’t been able to update its information technology systems to maximize staff productivity. (I suspect some people will be tempted to comment on the “productivity” of government employees, but I have found the FDA’s professional staff generally very qualified and hard working.)

On Tuesday, the Energy and Commerce Committee in the US House of Representatives held a hearing about the FDA’s ability to adequately oversee foreign production of medicines being sold in the US. This was part of the ongoing dialogue that was heightened by the contaminated heparin from China.  (The Government Accountability Office also released their study about foreign drug inspections on Tuesday.)

What I found interesting about reports from the hearing was its predictable political theatrical aspects: Chairman Dingell excoriating the FDA Commissioner for not admitting that the FDA needs more resources, and Commissioner von Eschenbach responded that he had asked for more funds to increase foreign inspections. But he also adhered to the Administration’s rhetoric that reforms are needed in addition to some extra funding. As the NY Times reports him saying, “the solution needs to be much more comprehensive than simply inspecting a facility.”

While this hearing focused on foreign inspections – which are clearly a concern – I believe the FDA also needs to step up their monitoring of medicines once they are already here in the US. While counterfeit medicines don’t appear to be a major problem in the US (at least yet), the continuing news reports of problems with generic medicines are worrisome – including a Wall Street Journal report that including the information that one patient’s generic pills had no markings, which is a violation of FDA regulations.

The FDA’s budget, staffing and technology challenges, together with the growing domestic and international quality and safety problems with various medicines raises concerns about how well prepared the FDA is to review and monitor biosimilar medicines and genomic based diagnostics.

I believe that Congressman Dingell is right, and that Commissioner von Eschenbach needs to be a stronger advocate for increased funding for the FDA, even if it means tearing up the Administration’s script he’s told to stick with. This Administration has only another 9 months of shelf life, so he doesn’t need to worry about being fired for speaking off-script – unless he is planning on running for office and wants to remain the good graces of the Republican Party. And if this is the case, then he is violating his duty as FDA Commissioner to fulfill the agency’s mission:

The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

I’ll get off my soapbox now, and check to see if the soap that came in it was made in China.

Medical information can change how clinicians treat patients, how patients care for themselves, and how healthcare payers promote or prevent the use of treatments and diagnostic tests. However, this information can act as either a broad sword or a scalpel, and produce good or bad outcomes.

A recent report from a Canadian new service about an article from the Canadian Medical Association Journal describing the outcomes from warning about the use of anti-depressants in children brings this issue down from a general concept to being very specific. This news report stated:

Two years after Health Canada warned about prescribing anti-depressants to children, the number of children and teens who died by suicide increased 25 per cent after years of steady decline, major new Canadian research shows.

And the increased suicide rate coincided with a 10-per-cent decrease in the rate of visits to doctors for the treatment of depression in children.

For the study, researchers tracked what happened in Manitoba before and after Health Canada warned in 2004 that newer antidepressants may be associated with an increased risk of “suicide-related” events in patients under 18.

They found the warning was followed by an overall 14-per-cent drop in antidepressant use among children and adolescents, fewer visits to doctors for depression, and - among eight- to 17-year-olds - increased rates of completed suicide.

More than 90 per cent of the children and teens who killed themselves were not taking antidepressants when they died.

Published Tuesday in the journal of the Canadian Medical Association Journal, the study is the first to document “such a wide range of unintended health consequences” from a major drug warning, the authors say.

Lead author Dr. Laurence Katz, a child and adolescent psychiatrist in Winnipeg, warns the increased risk of suicide could be a “random fluctuation.”

“We can’t say the warning, or the change in antidepressant use or the physician office visits caused changes in suicide rates,” says Katz.

The suicide rate among children and teens was also still relatively small, from 0.04 for every 1,000 children and adolescents before the warning, to 0.15 per 1,000 after.

But Katz worries the widely publicized drug warnings have led to more cases of untreated depression, and an impact “beyond what was intended.” The drop in doctors visits for depression suggests that some vulnerable children are getting no treatment, including psychotherapy, at all. He says his hunch is that families were afraid to go to the doctor for fear their child would be put on medication.

“But that’s not the only treatment for depression. Not going to the doctor deprives you of all forms of treatment.”

If anything, researchers expected office visits to go up after the warning was issued because physicians were urged to increase the monitoring of patients for potential adverse reactions.

Katz, an associate professor of psychiatry at the University of Manitoba, says the drug warnings and media response may have “generated a lot of fear.”

“Understandably parents who kept bringing their children, their teenagers in for troubles with depression were already struggling, and fearful (and) often appropriately cautious about whether their child or teenager should be put on a medication.”

Katz believes the findings could be applied to any Canadian jurisdiction. Other studies coming out of the U.S. are showing similar results. [Emphasis added]

The antidepressant warning involved drugs known as SSRIs, or selective serotonin re-uptake inhibitors, a class that includes Prozac, Paxil and Zoloft, as well as serotonin noradrenaline re-uptake inhibitors (SNRIs), which include Effexor. The drugs have not been approved in Canada for children, but doctors have prescribed them “off-label,” which they are legally permitted to do, to tens of thousands of toddlers, children and teens for depression, social phobia, anxiety and obsessive-compulsive disorders.

In 2003 the U.K. banned antidepressants for children. The only exception was Prozac. Studies have shown the drug is safe and effective in children.

A year later, Health Canada warned that people taking the newer-generation antidepressants may experience behaviour or emotional changes that may put them “at increased risk of self-harm or harm to others.”

Katz says he didn’t have a problem with the warnings themselves. But he says some people leaped to the assumption “that these medications lead people to kill themselves.”

[The report also notes that, “For young adults, there was no significant change in the rate of completed suicide.”]

Obviously, the outcomes found in this study are very worrisome, but it also a too dramatic example of the principle of unintended consequences.

It also reminds me of how a news story in the early 1990s about adverse reactions with the second medicine to treat AIDS.  This news report caused many AIDS patients to stop taking the medicine, and given that there was only one other medicine to treat AIDS, this certainly wasn’t a good thing for their long-term survival

Although correlations don’t prove causations, I think this study definitely underscores the importance of healthcare regulators - and their media colleagues - carefully considering how they present new health information and notices to the public - for both good findings or dire warnings. With all the proposals to empower patients to make their own decisions through consumer directed insurance plan, and to give people more health information, there should also be much more research into how people respond to health related information delivered in different forms from various sources.

I’m usually either supportive or neutral about alternative therapies because they generally aren’t harmful, and can be beneficial. However, there seem to be more and more recalls of these products by the Food and Drug Administration (FDA) for mislabelings that are significant, although seemingly not extremely dangerous.

On the other hand, I was struck by a press release I got yesterday from the FDA about a recall for the dietary supplement products “Total Body Formula” and “Total Body Mega Formula.” The recall was because these products had more than 200 times the amount of selenium than was printed on the products’ label – and the press release noted that, “Excessive intake of selenium is known to cause symptoms to include significant hair loss, muscle cramps, diarrhea, joint pain, fatigue, loss of finger nails and blistering skin.”

I guess this is another instance of how too much of something that is normally good, can be, well, not so good. And with 43 adverse reactions reported to the FDA, the recall seems like a very good thing.

UPDATE: The FDA updated their warning and information on this issue this afternoon - click here to see the FDA website notice.

After writing about Follow-On Biologics in a recent posting, I saw a notice about Health Canada’s proposal for how they would approve biologic products that are similar to already approved biologics whose patents have expired. They call these products Subsequent Entry Biologics (SEBs), and the proposal is open for public comment from March 14, 2008 until April 16, 2008.

While the draft guidance is lengthy, it does strike an overall well-balanced tone:

• “SEBs are not ‘generic biologics’”
• Approval of an SEB does not mean it can automatically be substituted for the original biologic that it is “similar” to
• Comparative studies will be required to generate data showing similarity to the original biologic in terms of quality, safety and efficacy

In many ways, the draft guidance is similar (no pun intended) to the process the US FDA used to approve some generic drugs prior to the 1984 Hatch-Waxman Drug Price Competition and Patent Term Restoration Act. (This was the law that created the abbreviated new drug application (ANDA) process which allowed generic drugs to only demonstrate bioequivalence, and obviated the requirement that they replicate the original drugs safety and efficacy trials.) By referencing published studies about the innovator drug as proof of safety and efficacy, these so called “Paper-NDAs” allowed generic companies to be approved much faster and more cheaply.

Health Canada’s “paper biologic licensing application” like proposal, would allow them to rely on published information about the original biologic, while also handling each SEB application individually to decide what additional studies need to be done to demonstrate quality, safety and efficacy of the SEB.

As I pointed out in my previous post, there are many levels of structural and biological complexity with biologic treatments, so Health Canada’s draft approach seems very appropriate and reasonable.

What do you think?