Ohio Health Lawyer & Attorney : Jayne Juvan : Benesch Friedlander Law Firm : Serving Columbus, Cleveland, Cincinnati, Toledo, Akron, Dayton, Parma, Youngstown, Canton, and Lorain OH

In attempt to more logically catalog posts, articles will no longer be posted under the heading "Juvan's Health Law Recap."  Nevertheless, this blog will continue to track legal developments affecting the health care industry on a weekly basis.

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With the presidential campaign full speed ahead, coverage of the candidates' views on health care has dramatically increased.  Unfortunately, though news coverage has increased, according to leading news organizations, as is often the case, many of the candidates are weary about presenting too defined of a plan for universal health care in fear that they may turn off certain supporters they desperately need  to win.  Focusing on the lackluster attention universal health care has gotten by the candidates in recent days, USA Today reports that

• Mitt Romney has refrained from highlighting plans for universal health care in speeches;
• Hillary is cautious in approaching the subject because of the negative press she received over her 1993-94 attempts at reform; and
• Others are concerned about balancing the need for universal health care against the backlash they might receive from insurance interest groups.

Attempting to differentiate himself from other candidates, John Edwards has gotten positive press for his calls to cure the system.  Recently, as quoted by the Associated Press, Edwards stated, "I believe this in my soul:  That no matter who your daddy is or where you live, or what the color of their skin is, every single one of us has value."  He continued, "But if we believe those things, we have to act on them.  If we believe that, we should have universal healthcare in our country." 

Perhaps the subject of universal health care hits closest home to Edwards, whose wife Elizabeth was recently diagnosed with an incurable recurrence of breast cancer.  When I asked Ms. Edwards about the Edwards plan for universal health care at a campaign stop to Cleveland after the news hit, Ms. Edwards stated that she understood that the worries from a devastating diagnosis are significantly exacerbated by financial woes when a patient lacks health care coverage. 

While some of the candidates are unwilling to be forthcoming with their plans, a few with less to lose politically took significant steps to reform the system last week.  Senator Edward M. Kennedy and Representative John Dingell introduced a bill that would extend Medicare coverage to all Americans, including those who are currently not eligible because of their age.  In a press release, Kennedy stated, "The nation's health care has reached such a crisis point that the American people are looking for bold action. . . . I believe that the best plan for the nation is to build on a program that all Americans know and respect by creating Medicare for All.  Medicare administrative costs are low.  Patient satisfaction is high . . . . And all Americans will be free from the fear of medical expenses that enable them to seek the best possible care when illness strikes." 

If you are interested in the subject of universal health care, see also Does Universal Health Care Have a Chance?

**Though this article provides a positive note about the Edwards campaign, Juvan's Health Law Update will aim in future posts to also highlight positives for the other candidates.

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The FDA has continued to aggressively fight the injunction issued by the District Court for the Eastern District of New York in Rx USA Wholesale v. Department of Health and Human Services, Food and Drug Administration.  The injunction issued in the case prohibits the FDA from requiring that secondary wholesale distributors of pharmaceuticals pass a pedigree that tracks each prior sale of a drug, a requirement that secondary wholesalers claim is impossible given that the statute and accompanying regulation do not impose a concomitant obligation on authorized distributors, or those distributors that have entered into an agreement with the manufacturers.

The FDA has appealed the lower court's ruling and most recently filed a brief urging the Second Circuit Court of Appeals to overturn the injunction.  The brief argues that (1) congressional intent is clear on the face of the statute that drug pedigrees must track the chain of custody back to the manufacturer, (2) the statute and regulations comport with the protections in the equal protection and due process clauses, as they are rationally related to Congress's desire to curtail pharmaceutical counterfeiting and consistent with Congress's findings that "non-authorized distributors were the avenue through which most diverted drugs entered the retail market and created public health dangers," and (3) the scope of the preliminary injunction is far too broad because it prohibits the FDA from requiring that drug pedigrees include the information set forth in subsections (1) through (5) of the regulation.  In the brief, the FDA states with respect to the latter argument that "Plaintiffs have not, and cannot, claim that it is impossible for them to supply this additional information, as it is readily apparent on the face of the drugs' labeling."

With the hold on the federal drug pedigree regulations requiring secondary distributors to trace the chain of custody back to the manufacturer currently in place, the focus has shifted to the states.  Last week, I received a call from an individual from the Texas legislature informing me of progress of the Texas drug pedigree legislation.  For those who are interested in tracking the legislation on a state by state basis, you can follow the developments of the proposed Texas law on the state legislature web site.  

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Last week, I attended and presented at the Pharma IQ conference entitled "e-Pedigree and Business Strategies for Drug Supply Security" held in Philadelphia, Pennsylvania.  At the conference, Tim Marsh from Pfizer, Inc. discussed Pfizer's anti-counterfeiting strategies, Dennis Luken, a detective with the Warren county, Ohio drug task force and the National Treasurer of the National Association of Drug Diversion Investigators reviewed the problem of drug diversion and counterfeiting in 2007, while Jim Christian from Novartis AG emphasized that RFID and track and trace technologies are not "solutions" to the counterfeiting problem.  Shay Reid, Vice President from Amerisource Bergen Corp., discussed Amerisource Bergen's attempts to become compliant with California's pedigree laws by 2009, and Robert Drucker from Rx USA Wholesale informed the audience about events that caused him to sue the FDA to prohibit the enforcement of regulations requiring secondary wholesalers to provide pedigrees tracing back to the manufacturer that fail to impose a concomitant obligation on authorized distributors.  Attorney Michael Levine also discussed his involvement in the case and the status of the injunction.  For those of you who are following the case, if you haven't already, I urge you to review the Pharmaceutical Market Access and Drug Safety Act of 2007, which includes language that, if implemented, would require manufacturers and authorized distributors of pharmaceuticals to likewise pass a pedigree.

While I was away in Philadelphia, the following stories made headlines:

• CMS Issues Proposed Decision Memorandum for Medicare National Clinical Trial Policy.  CMS has proposed revisions to its coverage policy for items and services furnished in a clinical trial.  As stated in the press release, the changes would include the following:
  • Renaming the policy as the Clinical Research Policy; 
  • Adding FDA post-approval studies and coverage with evidence development (CED) to studies that would qualify under this policy;
  • Requiring all studies to be registered on the NIH ClinicalTrials.gov website before enrollment begins;
  • Requiring studies to publish their results;
  • Paying for investigational clinical services if they are covered by Medicare outside the trial or required under an CED through the NCD process; and
  • Expanding the “deeming” agencies to all DHHS Agencies, the Veterans Administration, or the Department of Defense.  Deeming agencies are agencies that can “deem” whether a trial has met the general standards outlined in the policy.

See also the Proposed Decision Memorandum, available on the CMS web site.

• Kaiser Family Foundation Reports that Health Care Has Become an Important Campaign Issue.  The Kaiser Family Foundation summarized articles in leading newspapers reporting that health care has become a focus on the 2008 presidential campaign trail.  I would also recommend that readers review the New York Times Article "For Democrats, Health Care is a Rite of Passage."  As the election nears, Juvan's Health Law Update will begin tracking the views of the candidates on both sides of the aisle.

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Here's a review of some of the stories that captured the headlines last week:

• Money, Money, Money!  The Joint Commission on Taxation has reported that President Bush's proposal to create a standard tax deduction of either $15,000 for families or $7,500 for health insurance and categorize funds used for health insurance as taxable income would increase taxes paid by nearly $334 billion dollars in ten years.  Responding to the findings, Pete Stark stated that the conclusions "provide ample reason to doubt the plan's effectiveness and raise concerns about its cost." See also the CBO's Analysis of the Proposal. 
• FDA to Toughen Advisory Committee Membership Requirements.  Again taking a defensive posture, the FDA announced last week that it will implement a more stringent protocol to screen advisory committee participants to root out financial conflicts of interest.  Speaking of the new approach, Randall Lutter, the acting deputy commissioner for policy at the FDA, stated, "FDA is committed to making the advisory committee process more rigorous and transparent so that the public has confidence in the integrity of the recommendations made by its advisory committees . . . . Today's draft guidance document should provide more consistency in the consideration of who is eligible to participate in advisory committee meetings and would simplify the process."  See also the Draft Guidance; the FDA's Comment Submission Page; the FDA's Page on Advisory Committees; and Mark Senak's Review of the Requirements.
• Joint Commission.  The Joint Commission has released a report entitled Improving America's Hospitals: A Report on Quality and Safety.  Make sure to check it out!

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Generics--Drug Sales--Quality of Care

Here's a look back at a few noteworthy stories from last week...

• Biotech Generics.  Last week, FDA Commissioner Andrew von Eschenbach delivered a blow to makers of generics when he noted that generic versions of biotech drugs, which are generally more complex than chemical-based drugs and therefore more difficult to copy, will only be considered "similar" to brand name drugs.  As reported by the Washington Post, von Eschenbach stated at the PhMRA annual meeting, "We recognize that the end point would be what could be best described as similarity. Similarity in the sense that when a doctor gives you the product _ delivered it to a patient _ it will achieve an effect that is similar to the effect that we expected from the innovative . . . compound."  While the FDA is developing guidelines to evaluate generic versions, the Generic Pharmaceutical Association pointed out that the FDA does in fact have the "scientific knowledge to approve knockoffs, just as it now can sign off on the changes made by brand-name biotech companies in how they produce their drugs." 
• Drug Sales Increase in 2006.  IMS Health reported a 8.3% increase in drug sales last year and projects growth by 6-9% through 2010.  Diana Commy, corporate director, IMS Market Insights, commented on last year's growth by saying, “This growth was driven by factors that include an aging population and the introduction of the Medicare prescription drug benefit, which increased prescription coverage to the previously uninsured and underinsured, and provided generous plan benefits to seniors.” 
• JAMA Highlights Health Care Access and Quality of Care Issues.  On Wednesday, as reported by the Kaiser Family Foundation, the Journal of the American Medical Association published articles discussing access to health care and quality of care.  Here's a few of the conclusions reached in the articles:
  • "Patients without health insurance are less likely to receive treatment after injuries or diagnoses of chronic diseases."
  • "Patients in many cases do not receive necessary follow-up care, regardless of whether they have health insurance."
  • "Physicians should work in teams and measure the quality of care provided to patients to help reduce costs and reduce other problems in the U.S. health care system."
  • Spending on emergency care for recent documented and undocumented immigrants accounted for less than 1% of the North Carolina Medicaid budget annually between 2001 and 2004."

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Welcome to daylight savings time, which has been moved up from April!  Hopefully, the extra sunshine will calm the nerves of those whose blackberries are still an hour behind and whose calendar appointments are incorrect.  My calendar, for example, has shifted all of my lunch appointments to 10:00AM--so I'll either be finding myself drastically early for lunch or having brunch with acquaintances whose calendars are likewise confused.  If only the weather in Cleveland could also be affected by the change and undergo an early 50 degree shift in temperature...

On a more serious note...Generics, Generics, Generics! Generics made news on several fronts last week.  First, on Wednesday, the Senate Committee on Commerce, Science and Transportation Subcommittee on Interstate Commerce, Trade and Tourism reviewed the safety of drug importation.  At the hearing, Billy Tauzin, President and CEO of PhRMA,  stated that the closed system that blocks importation is the only way to ensure a safe supply chain.  Tauzin also launched attacks against those who argue that the cost savings of importation benefits consumers when he stated that "[m]ost of the savings would likely go to third party payers, such as insurance companies and HMOs."  Likewise, Randall W. Lutter, Acting Deputy Commissioner for Policy at the Food and Drug Administration, stated that the risk of receiving counterfeits is drastically increased when drugs are purchased online and that drugs purchased from foreign markets often have similar names but different active ingredients.  So--how is this news item tied to generics?  In his testimony, Lutter emphasized that generics, not imports, are the answer to cost control. 

In related legislation, lawmakers are also continuing to consider whether to ban negotiations between generic drug companies and makers of brand name drugs that effectively delay or prohibit the entry of lower cost drugs to the market.  The details of the hearing are set forth more fully in the post linked to above. 

Finally, lawmakers considered a bill last week that would provide the FDA with the authority to approve generic forms of biotech drugs.  Currently, the FDA lacks this authority because of the difficulty of creating generic equivalents of these drugs, which are made with living organisms.  As reported by the Kaiser Family Foundation, the proposed legislation requires that the drugs be comparable or interchangeable and that the principal molecular features be highly similar to the brand name. 

Merger mania revived!  Caremark RX, Inc. and CVS inched forward toward completion of their merger plan last week when a new proposal offered to increase by an addition $1.50 a special cash dividend, bringing the total to $7.50 per share.  As reported by the Wall Street Journal, the company post-merger would also "commence a cash tender offer for 150 million, or 10% of outstanding shares at a fixed price of $35 each."  The Wall Street Journal views this new offer as bringing "the competing proposals largely in line on a dollar basis" and giving CVS "a significant advantage in its ability to close the deal quickly."  While rival company Express Scripts has also raised its offer, Express Scripts currently does not have regulatory approval of its proposed deal from the Federal Trade Commission. 

Interested in an update on the NLRB's Oakwood decision?  On March 7, the BNA Daily Labor Report, which discussed the early impact of the Oakwood decision, stated that the fallout has thus far not been quite as severe as would have been originally anticipated.  However, while management attorneys speaking at a conference held by the American Bar Association stated that the "decision has not had much impact on supervisory determinations," union attorneys speaking at the same conference claim "that the full impact has yet to be felt." 

As previously discussed on Juvan's Health Law Update,  the NLRB held in Oakwood that charge nurses employed by an acute care hospital executed supervisory authority within the meaning of Section 2(11) of the NLRA because they assigned responsibilities to other nurses and exercised independent judgment in making these assignments.  

 

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As reported by the Kaiser Family Foundation and the American Health Lawyers Association, health care reimbursement and the financing crisis occupied health care news last week.  Here's a look at a few financing/reimbursement related stories: 

(1) New Physician Reimbursement Formula Proposed.  The Medicare Payment Advisory Commission issued a report on physician reimbursement that proposes a shift from the Sustainable Growth Rate formula (which, if continued, would cause a decrease of 40% over the next eight years) to an alternative reimbursement approach.  The Commission also suggested, inter alia, that physicians should receive more information regarding their overuse of procedures, that incentives should be adopted to encourage teamwork between providers, thereby increasing coordination, and that incentives should be adopted to encourage providers to provide more preventive care.

(2) Most Would Pay Increased Taxes to Fund Universal Health Care.  The New York Times and CBS issued results of a survey indicating that at least 60% of  adults would agree to pay higher taxes to fund universal health care.

(3)  9/11 First Responders Should Receive Medicare Benefits.  Lawmakers claimed that additional funding should be allocated to treat first responders to the 9/11 attacks.  To further that end, Senator Clinton and Representative Nadler will propose legislation to provide Medicare benefits to individuals with illnesses resulting from the aftermath of the attacks. 

(4) Spitzer Defends Health Care Cuts.  New York Governor Eliot Spitzer launched an ad campaign that defends his proposal to reduce spending on health care by $1 billion dollars. 

(5)  Medicare Part D Is Financially Irresponsible.  U.S. Comptroller General David Walker discussed the financial irresponsibility of Medicare Part D when he stated that "Medicare--barring vast reform to the program and the nation's healthcare system--is already on course to possible bankrupt the treasury and adding the prescription bill just makes the situation worse." 

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Last week, I visited Orlando, Florida for the American Health Lawyers Association Long Term Care in the Law Conference.  This week's Health Law Recap will focus on a few themes and trends identified at the Conference. 

• Shift in Long Term Care Reimbursement.  Leslie Norwalk, the Acting Administrator for the Centers for Medicare and Medicaid Services (CMS), focused on the increased pressure on the federal government resulting from the health financing crisis.  In response, federal reimbursement for long term care will shift in favor of home health agencies and away from skilled nursing facility care.
• Employee Education About False Claims Act.  Many attorneys expressed to representatives of CMS that there continues to be substantial and noteworthy ambiguities in connection with the Deficit Reduction Act employee education requirements.  One attorney noted that the requirement applies to an entity that has less than 5 million dollars in Medicaid payments if the entity is affiliated with other entities that receive 5 million or more in such payments.  Representatives for CMS have promised that further clarification will follow shortly.
• Plaintiffs' Lawyers Use Web Sites, E-Mail Addresses to Pierce the Corporate Veil.  There has been a strong trend for parent companies who acquire nursing home facilities to form separate subsidiaries to act as holding companies and operating companies for each nursing facility acquired.  One prominent defense attorney noted that plaintiffs' lawyers have begun to cite to web sites and e-mail addresses to build a case for veil piercing.  The lawyer cautioned that employees in each separate company should have different e-mail addresses. For example, if the parent company is named "Health Care Solutions, Inc.," one subsidiary is named "Brecksville Health Care Solutions, Inc."  and the other is "Madison Health Care Solutions, Inc.," the employees at the parent and both subs should not have their e-mail address as "employeename@healthcaresolutions.com."  Instead, the following e-mail addresses would help to show that the three entities are separate legal entities:
  • Parent Company:  employeename@healthcaresolutions.com
  • Brecksville Health Care Solutions, Inc:  employeename@brecksvillehealthcare.com
  • Madison Health Care Solutions, Inc:  employeename@madisonhealthcare.com

In addition, the attorney noted that legal counsel should review a company's web site and that the web site should clearly state that each facility is owned by a separate legal entity.

• Medicaid Fraud Enforcement Is on the Rise.  Many representatives of the federal government emphasized that, in the upcoming years, the government will have increased budgets to implement Medicaid fraud controls and pursue Medicaid fraud investigations.  In the past, Medicaid has not received the same scrutiny as have other federal health care programs. 

 

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Last week, Clevelanders spent most of their time digging out from the Valentine's Day Blizzard.  On Wednesday, the latest snowfall count in Northeast Ohio totaled eighteen inches, and today we received another six more.  To my friends who are glad that they don't live in a snow belt, there is an upside:  the snow was so bad on Wednesday that most businesses shut down and called it a snow day (the downside--most Valentine's Day deliveries were postponed until Thursday)!  Fortunately, I'll be leaving all of the snow behind and joining some of my friends in Florida who are laughing at our misfortune when I fly out to Orlando for a conference held by the American Health Lawyers Association.

Here's a look back at a few noteworthy events of the last week:

• The Delaware Chancery Court blocked the important Caremark/CVS merger vote, at least temporarily, thereby granting additional time to Express Scripts to launch its rival bid and gain antitrust clearance.
• Parade Magazine published an article about counterfeit drugs entitled Is Your Medicine Dangerous to Your Health? The article highlights that, while only 1% of drugs in the U.S. are counterfeits, counterfeiting is growing rapidly, several Americans have died from fake drugs and counterfeiters have taken in nearly $35 billion in profits.  However, as reported by Adam Fein, a lead author and expert on the issue of fake drugs, the article falls short in citing to RFID as the miracle cure for the problems in the supply chain.
• Lawmakers introduced legislation bringing Tobacco regulation within the FDA's jurisdiction, though there's still no clear indication that the FDA can handle its current responsibilities.

Looking to the upcoming weeks, the U.S. Court of Appeals for the District of Columbia will reconsider the Abigail Alliance case on March 1.  The case addresses whether terminally ill patients have a constitutional right to obtain access to experimental medications.

 

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Last week, the FDA cleared the way for the MammaPrint test, a diagnostic test designed to predict the likelihood of breast cancer recurrence.  As a person with a family member who has battled this terrible disease, I can attest personally to the fact that breakthroughs such as this continue to bring renewed hope to survivors.  While we all debate reimbursement rates, the impending health financing crisis and the like, one thing is certainly true:  positive developments in modern medicine truly do have the ability to change lives.

In addition to FDA clearance for MammaPrint, President Bush last week proposed reducing Medicare and Medicaid spending by $101 billion over five years.  In a controversial move, Bush has proposed to require wealthier seniors to pay higher Medicare premiums.  Some have criticized Bush for failing to address a reduction in underlying costs and instead simply "just lopping off the top."

Looking forward to the week ahead, make sure to watch for news from the House Subcommittee on Oversight and Investigations hearing on FDA drug review deficiencies.  The hearing is scheduled for Tuesday.

Finally, please note that, a few weeks ago, a reader alerted me to the fact that the comment feature on Juvan's Health Law Update was not enabled.  This was a minor glitch that occurred when the blog was shifted from Typepad to Lexblog.  Please note that comments have now been enabled.  I encourage all of you to participate in commenting in the future, and I apologize to those whose comments were not timely published.

Jayne

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Just when you thought the PDMA pedigree requirements set forth in 21 C.F.R. section 203.50(a) had retreated into the distance, the FDA attempted to breath new life into the law when it filed a notice of appeal before the Court of Appeals for the Second Circuit last week.  While the FDA has fought back, there's no indication whatsoever from RX USA Wholesale that it intends to back down from the suit. 

If the standard cited to in Magistrate Tomlinson's Report and Recommendation is in fact correct, it appears that the FDA has an uphill battle to fight to overturn the injunction.  The Report and Recommendation, citing other Second Circuit cases, states that the decision to grant a preliminary injunction rests in the district court's sound discretion.  A decision will only be overturned if the lower court abused its discretion.  Abuse of discretion occurs if a lower court "applies the wrong legal standard, rests its decision on a clearly erroneous finding of fact, or issues an injunction containing an error of form or substance."  The FDA will have to make a strong showing on at least one of these points to overturn the grant of the injunction. 

In other news from the FDA last week, the FDA has officially responded to a report issued by the Institute of Medicine last year that launched multiple criticisms against the agency.  The FDA further announced that it would begin sharing information with the Veterans Health Administration, a measure that many perhaps thought was already occurring.

 

 

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It's hard to believe that January is already coming to a close.  I immediately realized that we are full speed ahead into 2007 when I arrived at the gym this week, only to find that the parking lot was half full and that many of the good intentioned New Years resolutioners had dropped off!

President Bush's State of the Union address occupied the media last week.  I covered President Bush's proposed solution to the health care insurance crisis a week ago, so I will not delve too deeply into these issues again.  The Washington Post has followed the fall-out of Bush's proposal in two articles, one of which discusses the winners and losers in the plan (those who would buy individual insurance plans and those with employer-sponsored plans, respectively), and another of which states that the President's proposal received a "frosty reception from the Democrats."  Bush's proposal may be falling on deaf ears, as his support is waning.  As the bid for the White House looms closer, Juvan's Health Law Update will follow objectively (to the greatest extent possible) each of the candidate's views on health care. 

Last week I also had the most sincere pleasure of meeting Rita Schwab, author of the popular health care blog known as the MSSPNexus Blog, which I highly recommend.  For those of you who are unfamiliar, "MSSP" stands for medical staff service professional.  Rita currently works in provider credentialing at the Cleveland Clinic.  In addition to hosting the Health Wonk Review in the past (and receiving many accolades for her incredible coverage, I might add), Rita also covers provider credentialing, Joint Commission accreditation and patient safety concerns on her blog. 

Rita and I had a wonderful conversation over lunch at the "Blog Cafe," as she calls it.  We discussed issues affecting physicians and patients such as malpractice concerns and how the patient and physician communities might be brought more closely together.  We also discussed our love for blogging and how incredible it is to connect to new found friends from all over the globe.  I feel extremely fortunate to have met Rita, and so many other friends, through blogging!

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Last week,  many news stories centered around proposals by both the public and private sectors to provide coverage to the millions of uninsured.  President Bush, preparing for his State of the Union address, foreshadowed his proposal in his weekly radio address, and a large coalition of companies also launched a multi-phase proposal to expand coverage.  Meanwhile, Senator Grassley, in a defensive move, is preparing to filibuster the legislation recently passed by the House of Representatives that requires direct negotiation of Medicare Part D covered drugs, and Senator Leahy introduced legislation prohibiting reverse payments, or payments by brand-name drug companies to generic drug companies in return for a promise to delay market entry of generic equivalents. 

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• Pharmaceutical Companies Take Note:  Lawmakers Are Encouraging Bush to Strengthen Oversight of DTC Ads.  In November, the Government Accountability Office released a report entitled "Prescription Drugs: Improvements Needed in FDA's Oversight of Direct-to-Consumer Advertising."  The report criticized the FDA, stating that the agency's reviews of ads take too long and are becoming less effective.  The report further highlighted that the FDA also has thus far failed to implement a system to prioritize its reviews.  Last week, as reported by FDA News, Senator Herb Kohl drafted a letter to President Bush encouraging increased funding to tighten the review of these ads.  When the Democrats take control in January, Kohl will take over the subcommittee that oversees the FDA's funding.  Outgoing Majority Leader Bill Frist has echoed these comments, stating in a release, "Americans are besieged today with advertising for prescription medications.  Therefore, it is necessary for Congress to fully review the advertising practices of the pharmaceutical industry and federal regulatory practices to ensure patients are getting safe and effective prescription drug treatment."
• Merck Wins Another Vioxx Case.  An Alabama jury rejected Plaintiff Gary Abright's claim that the drug Vioxx caused his heart attack in 2001.  Responding to the verdict, an Associated Press article quotes Executive VP and General Counsel Kenneth C. Frazier as stating, "Juries continue to determine that Merck acted responsibly in its research of Vioxx and provided the appropriate information about Vioxx to patients and the medical community."
• GlaxoSmithKline Begins Phase III Clinical Trials for Herceptin Rival Tykerb.  Reuters reports that GlaxoSmithKline has begun a Phase III clinical trial to test Tykerb in early-stage women with Her-2 positive breast cancer.  The drug may receive FDA approval for women with late stage breast cancer sometime early next year, though FDA approval of the drug for women with early-stage breast cancer is still "many years away."  GSK also announced last week that it will acquire the UK's Domantis for $454 million, a deal that "doubles its presence in the biotech world but isn't expected to add materially to its revenue in the near future."
• Data Backup Tapes of Large Health Insurer Stolen in Ohio.  Last week, a large health insurer reported that data backup tapes that contained personal information for about 130,000 members were stolen from a vendor.  While accessing the information requires special commercial equipment, in an interview with Juvan's Health Law Update, James A. Kandrac, President of United Computer Group, Inc. based in Cleveland, Ohio, stated entities that store protected health information should consider over-the-wire encryption that can be transmitted electronically and vaulted off-site. Kandrac stated, "[T]o prevent the threat of non-encrypted data theft or loss, firms may consider a solution such as VAULT400, which safely and securely compresses and encrypts data for storage in an off-site electronic vault."

Please note that Juvan's Health Law Recap will not be published on December 24, 2006 and December 31, 2006.  Juvan's Health Law Recap will resume on January 7, 2007.

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