Juvan's Health Law & Private Equity Report : Corporate & Health Care Lawyer & Attorney : Jayne Juvan : Benesch Friedlander Law Firm : Private Equity, Corporate Governance

On Sunday, Juvan's Health Law Update included a post entitled ""Harvard School of Public Health Poll Finds Cancer Care Lacks Appropriate Coordination."  The post sparked an interesting conversation via e-mail with a breast cancer survivor from Canada I met a few months ago.  Juvan's Health Law Update has decided to include portions of this e-mail communication below because of the unique insight offered of Canada's health care system from a patient's perspective.  While the source requested to remain anonymous (we'll call her "Hope"), Juvan's Health Law Update has documentation substantiating the conversation.

On the U.S. and Canadian health care systems, Hope says,

[F]rom my point of view, US health care has the best and the worst of all worlds. It has some of the BEST health care in the world . . . and the worst.

This accounting and billing for every band aide and needle and tracking it all must be a stunning expense for your system - and clearly ridiculous for the patients. One Canada is definitely superior on.

I also read about the lack of coordination with all the doctors, and I was quite shocked to hear about this. In Canada, the "team" approach is very heavily emphasized with the doctors having set days in their calendars to get together and discuss not only all their cases in common, but also any difficult cases so that group's combined expertise and experience can come to bear on the patient's situation. The information, conclusions, exams and medical treatments are centrally filed and electronically accessible in everyone's office. And that means everything - all the data on my scans, MUGAs, blood work are available. It saves duplication since a test result might be useful to my regular GP to answer a different question than it was originally taken for by my oncologist. I can also access the information myself at no charge.

It does seem to me, though, for all it's flaws, that very superior medical treatment is available in the United States. But it appears that you have to be a good researcher, a strong advocate and have been smart enough to get the right kind of insurance to access the benefits. So the psychological stress on both patient and caregiver are much higher in the States........but that isn't as measurable as cash, is it?

One of the biggest problems with the Canadian health care system is access to care. The government rations access by creating waitlists that can be many months to years long. Years can be a long time to wait in a debilitated state for a joint replacement, for instance. People lose their jobs, quality of life and physical condition as they are stuck waiting in a chair or bed at home for their name to be called. The most urgent cases are always bumped to the front of the queue so that treatment is assured to the desperate, but who wants to BECOME the desperate?

Also the queue is regularly abused by connected queue jumpers. Politicians, celebrities, RCMP, certain ranks of civil servants - all jump to the front of the queue. Also, if you are injured on the job and are covered by worker's compensation - worker's compensation pays directly (not the government), so they jump to the front, while the great unwashed masses wait ever longer for their betters to be cured.

The worst abuse comes to those who are over the age of 70 who are deemed the least valuable. Rest assured that this ranking is not publicly acknowledged, but with a little bit of google, you can definitely verify my comments.

So our system offers increased coordination, but it isn't equally open to all.

Juvan's Health Law Update has not independently verified each of these statements.  Juvan's Health Law Update simply provides this commentary to show a view of the Canadian health care system from a patient's perspective.

Special thanks to Hope for authorizing Juvan's Health Law Update to publish this correspondence.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

As posted by the Complementary and Alternative Medicine Law Blog:

Cleveland Clinic's Preventive Cardiology team and the Canyon Ranch Institute are hosting a national conference highlighting the integration of conventional, complementary and alternative medicine and its impact on heart health.

"An Integrative Approach to Prevention & Regression of Coronary Artery Disease" will be held at the InterContinental Hotel & MBNA Conference Center Cleveland, Nov. 30-Dec. 2.

From the press release:

"Heart disease is the number one killer in the United States and we're struggling on how to effectively teach patients and practitioners about cardiovascular prevention," said Leslie Cho, M.D., Director, Women's Cardiovascular Center, Medical Director, Preventive Cardiology & Rehabilitation. "This conference will focus on the latest research as well as provide effective tools to help practitioners lower risk factors for heart disease, including treatments for obesity and smoking cessation techniques."

Tieraona Low Dog, M.D., a renowned integrative medicine expert, will serve as the event's key note speaker. She is Director of the Education Program in Integrative Medicine and a Clinical Assistant Professor in the Department of Medicine at University of Arizona College of Medicine. Dr. Low Dog promises to 'get to the heart of health' with her presentation "Integrative Medicine: A Bridge to the Future." She is scheduled to speak at the conference's opening dinner on Thursday, Nov. 30, at 7:00 p.m. in the Intercontinental Hotel and MBNA Conference Center Ballroom, second floor. This event is open to the public.

Dr. Low-Dog is Current Chair of the USP Dietary Supplements and Botanicals Expert Committee. Her honors and distinctions include a Presidential Appointment to the White House Commission on Complementary and Alternative Medicine in 2000 by Former President Bill Clinton. She was featured by Time magazine as 2001 Innovator of the Year in Complementary and Alternative Medicine and was appointed to the executive Advisory Board for the National Institute of Health's National Center for Complementary and Alternative Medicines in 2003.

The Cleveland Clinic-Canyon Ranch conference is expected to draw more than 250 cardiologists, internal medicine and family practice physicians, and nurse practitioners, to discuss the latest in diagnosis and therapeutic interventions in preventing heart disease. Through a series of didactic lectures, panel discussions and small group break-out sessions, the conference will focus on traditional and emerging testing and treatments for hyperlipidemia, hypertension, metabolic syndrome and diabetes. Moreover, it will focus on integrative approaches to the treatment of obesity, depression and smoking cessation.

"We're extremely proud to be participating in such an extensive meeting of the minds, and we're particularly excited about the conference's emphasis on integrative and preventive medicine," said Stephen Brewer, M.D., medical director of Canyon Ranch in Tucson. "For more than two decades, Canyon Ranch has worked to educate people on the importance of making lifestyle changes that lead to longer, healthier lives. This conference will highlight the benefits of this proactive approach, as well as the science behind it."

The nationally and internationally recognized experts also scheduled to speak throughout the conference include Leslie Cho, M.D., Director of the Women's Cardiovascular Center at Cleveland Clinic; Steve Nissen, M.D., Chairman, Cardiovascular Medicine, Cleveland Clinic; Stanley Hazen, M.D., Section Head, Preventive Cardiology, Director, Center for Cardiovascular Diagnostics and Prevention, Cleveland Clinic; and Marc Penn, Director, Bakken Heart-Brain Institute; Stephen Brewer, M.D.; and Mark Liponis, M.D., Corporate Medical Director, Canyon Ranch.

The conference opens Thursday, Nov. 30 at 8 a.m. with opening remarks by Delos M. "Toby" Cosgrove, M.D., CEO and President of Cleveland Clinic. A series of series of lectures will be given the morning of Friday, Dec. 1, while a variety of smaller break out sessions will bring the conference to a close.

For an agenda or for more information about the Cleveland Clinic and Canyon Ranch "Integrative Approach to Prevention & Regression of Coronary Artery Disease" conference, visit http://www.clevelandclinicmeded.com/summit/preventcardio06/default.htm.

About Cleveland Clinic
Cleveland Clinic, located in Cleveland, Ohio, is a not-for-profit multispecialty academic medical center that integrates clinical and hospital care with research and education. Cleveland Clinic was founded in 1921 by four renowned physicians with a vision of providing outstanding patient care based upon the principles of cooperation, compassion and innovation. U.S. News & World Report consistently names Cleveland Clinic as one of the nation's best hospitals in its annual "America's Best Hospitals" survey. Approximately 1,500 full-time salaried physicians at Cleveland Clinic and Cleveland Clinic Florida represent more than 100 medical specialties and subspecialties. In 2005, there were 2.9 million outpatient visits to Cleveland Clinic. Patients came for treatment from every state and from more than 80 countries. There were nearly 54,000 hospital admissions to Cleveland Clinic in 2005. Cleveland Clinic's Web site address is www.clevelandclinic.org.

***
Law Offices of Michael H. Cohen offers general corporate legal services, litigation consultation, and expertise in health law, with a unique focus on alternative, complementary, and integrative medical therapies.

Michael H. Cohen is also President of the the Institute for Integrative and Energy Medicine, also known as the Institute for Health, Ethics, Law, Policy & Society. The Institute serves as a reliable forum for investigation and recommendations regarding the legal, regulatory, ethical, and health policy issues involved in the judicious integration of complementary and alternative medical therapies (such as acupuncture and traditional oriental medicine, chiropractic, massage therapy, herbal medicine) and conventional clinical care.

The most recent book written by Michael H. Cohen on health care law, regulation, ethics and policy pertaining to complementary and alternative medicine and related fields is an interdisciplinary collection of essays entitled, Healing at the Borderland of Medicine and Religion. This is the fourth book in a series, the first being Complementary and Alternative Medicine: Legal Boundaries and Regulatory Perspectives (1998).

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Except for the D.C. Circuit's order vacating the May 2, 2006 ruling in the Abigail Alliance case, last week was a relatively quiet week on the news front (though a quite busy week on the work front, as clients called continually looking for results before the holiday) because most of us retreated to celebrate Thanksgiving.  Nevertheless, I have summarized a few interesting stories below:

• Harvard School of Public Health Poll Finds Cancer Care Lacks Appropriate Coordination.  A Harvard School of Public Health, USA Today and Kaiser Family Foundation poll found that fifty percent of patients and family members surveyed have difficulty coordinating cancer care.  While some respondents reported being confused about their prescriptions, others reported being sent for duplicate tests and receiving conflicting information.  In a USA Today article reporting the findings, one caregiver, who stated that a technician almost performed a CT on her son's stomach instead of a brain scan, said, "It was my first lesson in being an advocate for my child."  Another caregiver, a former oncology nurse at the National Institute of Health who left her job when her husband was diagnosed with lukemia, reported compiling all test results before appointments so that doctors would not have to scramble to locate the appropriate information.  She states, "I wanted to concentrate on [my husband's] care, not chasing paper trailes and filling people in on what was going on because his chart wasn't there." 

Gabriel Hortobagyi, president of the American Society of Clinical Oncology and chair of breast medical oncology at the M.D. Anderson Cancer Center, summarizes the problem when he says, "Patients say, 'I have five or six doctors, but no one is in charge of the show.'  This is the perfect scenario for disrupted and piecemeal care."  Hortobagyi reports that patients who receive treatment from comprehensive care centers may ultimately have better results at least in part because they are able to meet with all of their doctors together.  While this may be an optimal situation, the article reports that only about ten percent of patients obtain their care from comprehensive care institutions such as the M.D. Anderson Cancer Center.  To bridge the gap, Hotyobagyi reports that ASCO is developing care models and hopes to release these models in the Spring.  Although such models may assist with increased coordination, development of care plans is often met with resistance because insurance companies generally do not pay physicians to coordinate care.

Ellen Stovall, president and CEO of the National Coalition for Cancer Survivorship, states that every patient should be provided with at least the following documents:  (1) a care plan outlining the doctors' plan to treat the patient's cancer; (2) a treatment summary that includes a listing of all necessary surgeries, raditation treatments and drugs and their specific doses; and (3) an ongoing care plan setting forth the steps patients should take to monitor their health.

USA Today published three related articles, including the following:  (1) "Cancer Hurts Caregivers, Too," finding that a third of respondents surveyed by the Harvard School of Public Health/Kaiser Family Foundation/USA Today reported that caregivers experienced emotional and psychological trauma associated with their loved one's illness; (2) "Cancer Patients Keep on Working," reporting that one in ten cancer patients subsequently change positions or jobs because of their illness; and (3) The Upside of Cancer: A New Outlook on Life, reporting that many cancer patients are positively changed from the experience.  See also Survey Results at the Kaiser Family Foundation's Web Site and the Harvard School of Public Health's Press Release.

• Ohio Company Recalls Turkey and Ham.  According to USA Today, HoneyBaked Foods, Inc. voluntarily recalled 46,941 pounds of turkey and ham products sold in Toledo, Ohio and on the internet that may be contaminated with listeria monocytogenes that could cause a potentially life threatening disease known as listeriosis.  Infants, the elderly and individuals with HIV are the most susceptible to the disease.  Thus far, there have not been any related reports of illness.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

I highly recommend that readers of this blog interested in the pharmaceutical industry visit Drug Channels, a blog hosted by Adam J. Fein, founder and president of Pembroke Consulting, Inc. based in Philadelphia.   Fein includes incisive commentary about the pharmaceutical industry, including most recently unique perspectives on the profitability of generics and Wal-Mart's $4 generic program.  The following is a list of recent posts:

• The Attack on Generic Profits in Drug Channels;
• Wal-Mart Raises the Stakes; and
• New York Times Editors Read This Blog.

While he certainly seems to be an expert in the field, Fein is as humble as they come, stating at the end of one post, "Hey, I'm just one voice out there, so please don't forget Newton's Second Law of Consulting: For every expert, there is an equal and opposite expert."

• Email This
• Print
• Comments (1)
• Trackbacks
• Share Link

Last week, the United States Court of Appeals for the District of Columbia Circuit granted a rehearing and vacated the May 2, 2006 decision of a three judge panel holding that a terminally ill mentally competent adult excluded from Phase II clinical trials has the right, under the Fifth Amendment Due Process Clause, to use post-Phase I investigational drugs that do not have FDA approval for commercial distribution.  Chief Counsel for the Washington Legal Foundation speculates that all ten judges for the D.C. Circuit will hear the case sometime next summer. 

In 2003, Abigail Alliance brought suit against Andrew C. von Eschenbach, acting Commissioner of the FDA, and Michael O. Leavitt, Secretary of the U.S. Department of Health and Human Services, after the FDA rejected Abigail Alliance's formal request to make post-Phase I drugs available to terminally ill patients who are not clinical trial participants.  After the FDA's rejection of the proposed policy, Abigail Alliance filed a Citizen Petition challenging the FDA's decision.  While the FDA acknowledged the receipt of the Citizen Petition, the FDA failed to respond within the requisite 180 day time period, thereby entitling Abigail Alliance to seek judicial review.   Abigail Alliance then brought suit to enjoin the FDA from enforcing its current policy that bans the use of post-Phase I investigational drugs by terminally ill patients excluded from Phase II clinical trials.

The May 2, 2006 appellate court opinion in the Abigail Alliance case, filed by a three judge panel, applied the substantive due process test established in Washington v. Glucksberg, 521 U.S. 702, 710 (1997), which includes a two-fold analysis to determine whether a right is fundamental and warrants due process protection. The Glucksberg test requires a court to first determine whether the right asserted is "objectively, deeply rooted in this Nation's history and tradition." Second, the court must evaluate whether the asserted right is "implicit in the concept of ordered liberty, such that neither liberty nor justice would exist if [it] were sacrificed." 

Examining the first inquiry, the court stated that, "[d]espite the FDA's claims to the contrary, . . . it cannot be said that government control of access to potentially life-saving medication 'is now firmly ingrained in our understanding of the appropriate role of government' . . . so as to overturn the long-standing tradition of the right of self-preservation."  Regarding the second inquiry, the court held that the right asserted by Abigail Alliance could be inferred from the Supreme Court's ruling in Cruzan v. Director, Missouri Dept. of Health, 497 U.S. 261 (1990), which found that individuals have a constitutionally protected right to refuse life saving medical treatment.  Accompanying this right, the court stated, is "the right to access potentially life-sustaining medication where there are no alternative government-approved treatment options . . . . [T]he key is the patient's right to make the decision about her life free from government interference." 

After concluding that the right asserted by Abigail Alliance merits due process protection, the court remanded the case to the district court to determine whether the FDA's current policy withstands the application of the rigorous strict scrutiny review--essentially, to determine whether the policy is narrowly tailored to serve a compelling governmental interest.

Blogosphere Confusion

As noted by How Appealing, apparently there was some confusion in the blogosphere about the D.C. Circuit's ruling. On the same day that the D.C. Circuit issued the order vacating its decision, the three judge panel also denied the defendants' request for a panel rehearing.  While the D.C. Circuit posted online the panel's explanation for denying rehearing, the "D.C. Circuit did not post online as a published opinion the court's order granting rehearing en banc in the case."   Because the order granting a rehearing en banc was not published but the order denying panel rehearing was published, "[a]nother law blogger depicted yesterday's D.C. Circuit developments as a loss for the federal government, which was correct based on available information but absolutely incorrect once the previously unknown grant of the federal government's petition for rehearing en banc became public."  The other blogger referenced maintains that the post was in fact correct, but nevertheless, this was very confusing.

Accordingly, How Appealing argues that "all federal appellate courts should begin to follow the approach of the Fifth and Ninth Circuits in posting online as published opinions those courts' orders granting rehearing en banc. A federal appellate court's decision to grant rehearing en banc in a case is a significant development that should not remain hidden from the public inside a password-required PACER docket."

• Email This
• Print
• Comments
• Trackbacks
• Share Link

• FDA Approves Silicone Gel Implants.  On Friday, the Food and Drug Administration announced the approval of silicone gel-filled breast implants after allegedly undertaking a "rigorous scientific review" that, at least it seems, yielded strikingly similar information to that which has been known for more than the last decade.  Women report that they prefer these implants, which the FDA banned about fourteen years ago, because they are purportedly more natural and appealing than saltwater filled implants.  While the FDA claims that a majority of the women who participated in clinical trials for these devices were satisfied with their results, safety concerns still abound, as "complications [were] reported in the core studies includ[ing] hardening of the area around the implant, breast pain, change in nipple sensation, implant rupture and the need for additional surgery."  Responding to these safety concerns, the FDA indicated that appropriate patient labeling will sufficiently warn consumers of the risks associated with the use of these devices.  As a result, warnings must state that (1) these devices are not lifetime devices; (2) consumers will probably need additional breast surgeries later in life; (3) changes that occur to a woman's breast as a result of the implants are likely irreversible; and (4) because there is a strong likelihood that these implants will rupture and that such ruptures are generally "silent," a woman should have an MRI to detect a silent rupture three years after surgery and every two years thereafter.  The FDA further suggested that, if a rupture is detected, the implant should be removed and replaced.  Despite the FDA's report, is it really likely that the average consumer will be sufficiently informed to appreciate the risk?  Will the average consumer be in a position to obtain the level of care necessary later in life? 
• Forbes Reports Earnings for Pharma Stocks.  "Pharma Stocks Gain on M&A, FDA Approvals," Forbes reported at the close of last week.  According to Forbes, the Nasdaq Biotech Index closed up 1.90% and the AMEX Pharmaceutical Index rose 2.2%.  Forbes also reports that Johnson & Johnson announced the acquisition of Conor Medsystems, a company that markets a drug-eluting stent in Europe that will likely be on the market in the U.S. sometime in 2008.  Meanwhile, Merck posted a 4.5% increase, possibly attributable to its victory in a Vioxx suit brought by a New Orleans man who argued that the drug caused his non-fatal heart attack. While Genentech received good news last week with the expanded FDA approval of its "miracle drug" Herceptin for patients with early-stage breast cancer, RBC Capital Markets believes the approval will not translate to better-than-expected sales since the drug has, for the past year, been used in these patients. 
• Results of Ohio's Med Mal Study Released.  Ohio's tort reform legislation required the tracking of data to substantiate claims that lawyers and jury verdicts were the cause of substantial increases to med mal insurance rates.  On Tuesday, the Ohio Department of Insurance released the results of 5,000 med mal cases.  The study found that about twenty percent, or 1,046 out of 5,051, of the cases filed resulted in an award to the plaintiff.  The average award, either through settlement or jury verdict, totaled about $270,000, though claims filed in Northeast Ohio received payments totaling around $300,000.  All in all, the amounts awarded reached $281,764,938.  Sixty-five of the claims resulted in a payout of over $1 million.
• Bush Criticized for HHS Family Planning Programs Appointment.  Last week, the Bush Administration announced the appointment of Eric Keroack, a previous medical director who worked for an organization that views contraceptives as "demeaning to women."  Democrats quickly fired back at this nomination, arguing that the move parts with Bush's post-election promises of bi-partisanship.  According to the Washington Post, the appointment does not require Senate confirmation. 

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Today, the FDA announced the expanded approval of Herceptin (also known as trastuzumab), a targeted therapy, for the treatment of women with early stage Her-2 positive breast cancer, a form of breast cancer previously known for its resistance to certain types of chemotherapy regimens. 

In 1998, after showing positive results in clinical trials, Herceptin received FDA approval for use in women with Her-2 positive metastatic breast cancer.  Researchers thereafter conducted clinical trials assessing the use of Herceptin in combination with chemotherapy treatments such as Adriamycin, Cytoxan, Taxol or Taxotere in women with early stage breast cancer.  In 2005, several of these trials were halted early due to findings that the percentage of women with disease free survival improved drastically.  Because of these findings, the use of Herceptin in women with early stage breast cancer has been the standard of care for about the past year.

Speaking about Herceptin, Dr. Edward Romond, professor of hematology/oncology at the University of Kentucky, said, "This is the largest improvement in outcome for any group of women with breast cancer in 25 years." 

If you are interested in hearing success stories directly from women touched by Her-2 positive breast cancer and diagnosed at all stages of the disease, tune in to www.her2support.org. 

This post is dedicated to Diane Juvan.  Special thanks to Michael H. Cohen for alerting me to this development.

• Email This
• Print
• Comments
• Trackbacks (1)
• Share Link

Benesch Friedlander Coplan & Aronoff, LLP announced today that Jayne Juvan's podcast entitled "Blogging for Lawyers" will air on DJ Flash Ferenc's radio show this Saturday morning between 10 and 11 a.m. on WERE.  Make sure to tune in! 

Benesch's podcast series "The Benesch Beat" was developed by Mark Avsec, an Intellectual Property lawyer at Benesch who is known for being a former keyboardist for Wild Cherry and a Grammy nominee for the hit song "Play that Funky Music, White Boy." 

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Yesterday, Michael H. Cohen, author of the Complementary and Alternative Medicine Law Blog, reported that "Scientists have taught dolphins to combine both rhythm and vocalisations to produce music, resulting in an extremely high-pitched, short version of the Batman theme song."  While the headline is amusing to some, Cohen questions the activity, asking "why dolphins are taught to sing the theme from Batman and not Beethoven's Ninth."

He continues,

Maybe the discrepancy has to do with the fact that I've placed this post under the heading of "ethical issues," whereas others have questioned whether recording the dolphins will raise intellectual property issues.

I noticed that a related article is entitled, Dolphins better at networking than the Web. Which is where my intuitive leap had intially gone: the question for science is not what songs dolphins can learn from the warped parts of our minds . . . . The question is rather what tunes we can learn from the dolphins.

"People who develop complex networks, like the World Wide Web or electricity grids, could learn a lot from the social behaviour of dolphins, a New Zealand zoologist has found.

David Lusseau, a zoologist at the University of Otago spent seven years observing a community of 64 bottlenose dolphins in Doubtful Sound, New Zealand, and found they have a social structure similar to human and human-made networks.

Cohen concludes,

Our dolphin friends may just be a leap or two ahead of our own ability to communicate through the five senses. Training dolphins to repeat commercialized popular culture for our own entertainment seems like throwing the precious pearl of consciousness to the swine of instant gratification.

***
Michael H. Cohen is the President of the the Institute for Integrative and Energy Medicine, also known as the Institute for Health, Ethics, Law, Policy & Society. The Institute serves as a reliable forum for investigation and recommendations regarding the legal, regulatory, ethical, and health policy issues involved in the judicious integration of complementary and alternative medical therapies (such as acupuncture and traditional oriental medicine, chiropractic, massage therapy, herbal medicine) and conventional clinical care.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Merck & Co., Inc., vowing to fight individually each of the 24,000 suits against it alleging that the company failed to adequately warn consumers about the harmful side effects of Vioxx, an arthritis drug, and that Vioxx caused heart attacks, received a favorable verdict from a New Orleans jury today.  Vehemently opposing the claim that Vioxx caused Charles Mason's heart attack, attorneys for Merck argued that Merck complied with all reporting obligations and that other health factors were at the root of the cause of Mason's condition.  Phil Beck, an attorney for Merck, reflected on the victory, stating, "We thought the evidence showed clearly that first, Mr. Mason had not taken Vioxx for several days before his heart attack, and second, that there was no (blood) clot that could have come from Vioxx."

Thus far, Merck has successfully won seven out of eleven cases that have gone to trial, though in one the court ordered a new trial because additional evidence subsequently surfaced.  The Dean of Williams University School of Law David Logan has speculated that Merck will allow several more suits to go forward before deciding whether to settle with plaintiffs collectively.

News of the verdict hit before the NYSE closed.  Merck finished off the day at 44.15, up slightly, but still down from the 52 week high of 46.37.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Not even a week out from elections, and amid cries for bipartisanship and teamwork, Democrats and Republicans have already begun sparring.  Yesterday, Juvan's Health Law Update reported that Nancy Pelosi, the future Speaker of the House, has called for negotiations with pharmaceutical companies over drug pricing.  Today, the New York Times reported that the Bush Administration stepped forward to express its strong opposition to Pelosi's proposed change.  Speaking on behalf of Republicans, Health and Human Services Secretary Michael Leavitt went on the record announcing his opposition to the Democrats' plan, stating, "Government negotiation of drug prices does not work unless you have a program completely run by the government.  Democrats say they want the government to negotiate prices.  What they really want is government run health care."

Pharmaceutical companies have also voiced their opposition, raising the concern that this new initiative will result in the government receiving the "best price" for drugs.  Similarly, former president of Anthem Prescription Management James Lang stated, "For this to work, the government would have to take over price negotiations.  It would have to take over formularies.  You can't do one without the other."

While some have urged the Democrats to adopt a "go slow approach," Democrat Pete Stark responded by saying that there's no good reason to wait and that "quick congressional action might save a life."  He thereafter added, "I believe we must start work immediately to improve this incomprehensibly complicated plan, which overpays and deregulates private plans to the detriment of beneficiaries and taxpayers."

And thus, the promises of bipartisanship quickly retreat into the background, perhaps only to emerge again in the next election.

• Email This
• Print
• Comments (1)
• Trackbacks
• Share Link

Last week, with the elections, the Dems taking over control of both the House and the Senate, and the resignation of Defense Department powerhouse Donald Rumsfeld, was a busy week for many health care lawyers who found themselves fielding multiple calls and inquiries from clients about the effect the shift in power will have on health care providers and companies.  A few potential changes are noted below, along with a short recap of the FDA's new post-market monitoring program of medical devices.

• Democrats May Cut Medicare Payments to HMO Plans.  The Boston Globe reports that Representative Pete Stark, a Democrat from California, wants to remove the boost to Medicare HMOs granted in 2003.  Currently, the HMO payments are about 11% higher than those paid by Medicare to doctors and other providers.
• Future Speaker of the House Nancy Pelosi Vows to Seek Discounts for Medicare on Prescription Drugs.  The Washington Post reports that Nancy Pelosi, the first lady Speaker of the House, has promised legislation allowing Medicare to negotiate the price of drugs directly with pharmaceutical companies.  Ira Loss, an analyst quoted in the article, stated that "[t]he drug industry is on the top of the list of industries that would be uncomfortable if Democrats are successful in the elections."  Pharmaceutical companies have responded that Pelosi's proposal "equates to price controls."  Quoted in a report by the Kaiser Family Foundation, Catherine Bennett, a pharmaceutical industry lobbyist, stated that allowing direct negotiation "would just be chilling."  Bennett continued, "If the federal government is suddenly setting the cost of your product, you might get short-term savings in the Medicare program, but where do you get the money for the next generation of innovative drugs?"

On Wednesday, shares of Pfizer, Inc. tumbled to $26.62, a 43 cent decline, Eli Lilly & Co. closed at $56.48, down fifty cents and Merck & Co. fell to $44.34, a $1.56 loss.  On Friday, the losses continued, as Pfizer closed at $25.71, Eli Lilly at $54.14 and Merck at $43.12.

• FDA to Strengthen Post-Market Monitoring for Medical Devices.  Last week, the FDA announced that it will strengthen post-market monitoring of medical devices.  Scott Gottlieb, M.D., the Deputy Commissioner for Medical and Scientific Affairs, stated in a press release, "Many of today's medical devices are smaller and more complex than ever, offering new medical opportunities that have benefited literally millions of people. But this technical sophistication sometimes means the margin for error with device manufacturing shrinks and so we need to be working even harder, after devices and engineering changes are approved, to monitor for potential safety problems."  As reported by the FDA, the changes include the following:
  • creating a cross-cutting organizational structure within CDRH to better integrate pre-market, post-market and enforcement efforts;
  • developing internal performance measurements to track the center's handling of post-market issues, such as recalls;
  • pursuing the development of a unique identifier system to identify a device and the information associated with that device throughout its lifetime;
  • proposing mandatory use of electronic reporting for required adverse event reports and revising the current system that records reported adverse events for devices (the Manufacturer and User Facility Device Experience Database or MAUDE system);
  • increasing the use of Medical Product Safety Device Network (MedSun) programs--a network comprised of more than 350 hospitals that have been recruited and specifically trained to identify and report device problems, and help provide "real time" data on signals and safety problems;
  • enhancing risk/benefit communication efforts so health practitioners, patients and consumers receive clearer and more timely information on public health news; and
  • increasing the coordination among the agency's compliance and enforcement programs.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

This week, Michael H. Cohen, Assistant Clinical Professor of Medicine, Harvard Medical School and Assistant Professor, Harvard School of Public Health, announced on the Complementary and Alternative Medicine Law Blog  that the Institute for Integrative and Energy Medicine (the "Institute") is "reaching critical mass toward sustaining its mission," which is "[t]o provide leadership for the transformation of global healthcare toward compassionate and caring models, supported by law and social policy, that bridge our physical, psychological and spiritual selves." 

As reported at www.ihelps.org, the Institute collaborates with international scholars and organizations to develop models of health care that:

• draw on and respect our planetary heritage of healing;
• acknowledge the rights, interests, and needs of patients and families;
• understand health and healing as spiritual and emotional as well as physical journeys; and
• regard human transformation as central to a compassionate, caring healthcare system.

While originally a Wall Street lawyer who worked in securities, banking, mergers and acquisitions, Cohen shifted his focus, breaking from traditional corporate legal practice, and spent the last several years of his career writing and reflecting about complementary and alternative medicine (CAM). Cohen's shift occurred after taking up the study of Ericksonian hypnotherapy, Gurdjieff Work, and other tools for investigating consciousness, and following graduation from the New Seminary in New York and the Barbara Brennan School of Healing in Florida.

Cohen defines CAM therapies as "those therapies traditionally outside those provided through conventional, biomedical care in hospitals."  CAM methods include, for example, acupuncture, aromatherapy, chiropractic, homeopathic medicine, naturopathic medicine, Qi gong, Reiki and therapeutic touch.  "Integrative healthcare," he writes, "refers to emerging models of health care that integrate CAM into conventional medical settings, endeavor to create optimal healing environments, and bridge the entire spectrum of therapies." 

Cohen has spent much of his time discussing deficiencies in the legal framework that hinder CAM providers from gaining general acceptance.  States and medical boards, for example, fail to license and credential CAM providers in a fashion similar to that of physicians and other providers of conventional medicine.  Legislative recognition of these providers is important, however, because, as Cohen and several of his colleagues write, "legislative recognition trumps medical recognition:  State legislatures can license providers and thereby grant citizens access to certain therapies, even if scientific debate has not concluded in favor of those modalities." Similarly, in another article, Cohen and others explored the malpractice implications of referrals to CAM providers.  "Referrals can generate direct liability (the decision to refer was itself considered to be negligent, resulting in patient injury) and vicarious liability (the referring physician becomes legally responsible for the treating practitioner's negligence)." Accordingly, because of the risk of malpractice exposure, physicians have become hesitant to refer to patients to CAM providers.

The failure to have consistently applied standards serves as an impediment to patients who desperately need complementary therapies that provide a sense of hope and empowerment--the sense of actively combating and taking control of the disease that resides within them.  Cohen, for having the audacity to delve deep into CAM, has assumed a noble role. My recent conversations with Cohen have also led me to believe that he is a great mind and a deeply compassionate soul. 

With Cohen's theories, writing and advocacy, Cohen has the ability to increase the availability and credibility of CAM therapies, thereby helping to bring about a transformation for those whose illness initially held them captive and in a state of despair.

Juvan's Health Law Update will continue to follow the Institute's progress and will keep you apprised as developments occur.  If you are interested in furthering the development of the Institute, please contact Michael H. Cohen directly.

• Email This
• Print
• Comments
• Trackbacks (1)
• Share Link