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

Yesterday, in a devastating blow to terminally ill patients seeking use of experimental drugs, the United States Supreme Court refused to hear an appeal of a ruling by a divided federal appeals court that denies the right of access. 

Juvan's Health Law Update has been following the case for some time.  For coverage of the case by this blog, see D.C. Appeals Court Rules Against Abigail Alliance and D.C. Circuit Vacates Abigail Alliance Decision, Orders Rehearing.

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Yesterday, the United States Court of Appeals for the District of Columbia Circuit, overturning a panel decision of judges in the same court in a case filed in 2003 by the Abigail Alliance for Better Access to Developmental Drugs, found that there is no fundamental right "deeply rooted in this nation's history and tradition" to access experimental medications before they receive approval from the United States Food and Drug Administration. 

Related Reading:

New York Times, Court Rejects the Right to Use Drugs Being Tested

Washington Times/Associated Press, Terminally Ill Lose Case for Shot at Experimental Drugs

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Targeted Genetics Corporation ("Targeted Genetics") has alerted the Food and Drug Administration ("FDA") that a patient who received an investigational drug for the treatment of active inflammatory arthritis died shortly after injection.  The clinical trial is now on hold, meaning that enrollment is currently closed and the more than one hundred current participants will no longer receive doses of the drug. 

Describing the drug, the FDA states,

The product that was being studied uses a particle called a vector that is designed to deliver treatment genes to target cells. The vector used is a recombinant adeno-associated virus (AAV) derived vector and delivers the gene for Tumor-Necrosis Factor -Receptor, with the intent to inhibit a key mediator of inflammation. In the study, the gene therapy was administered into the joint affected by the disease to reduce inflammation and disease in patients with active inflammatory arthritis.

The FDA, with the assistance of the National Institutes of Health, is investigating whether the event was related to the treatment and stated that Targeted Genetics is cooperating with the investigation. 

 

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"Oncologists do not usually need bodyguards when they present scientific data at a medical symposium," writes Rob Stein of the Washington Post, "[b]ut when Howard I Scher of Memorial Sloan-Kettering Cancer Center and Maha Hussain of the University of Michigan spoke at a recent meeting of the American Society of Clinical Oncology, they were in fear of their safety." 

According to Stein, the two physicians encouraged the Food and Drug Administration ("FDA") to delay approval of Provenge, a drug designed to treat advanced prostate cancer, causing some investors, patients and patient advocates to voice their dismay.  Some, he reports, have placed "vitriolic postings" on the internet, while, according to the two doctors, others have threatened them.  Of the threats, Hussain stated, "We have been harassed and trashed for giving our opinion in an area of our expertise. . . . It's been a nightmare, to say the least." 

Frank Burroughs, a spokesperson for Abigail Alliance, the group that sued the FDA in attempt to obtain increased access to experimental medications for the terminally ill, voiced support for allowing access to the drug for terminally ill patients.  He stated, "What we're saying is that when you have a drug like Provenge, you should let people have access to it who have run out of options."

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The Health Rythym Society has reported that a preliminary study has indicated that iPods and other MP3 players may interfere with pacemakers.  According to the press release,

Continue Reading...

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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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Last week, the FDA approved Tykerb, a targeted therapy for the treatment of women with advanced Her-2 positive breast cancer.   While similar Herceptin, Genentech's Her-2 blockbuster, Tykerb differs from Herceptin in a meaningful way.    "Unlike, for example, trastuzumab [Herceptin]--a monoclonal antibody, which is a large protein molecule that targets the part of the HER2 protein on the outside of the cell--Tykerb is a small molecule that enters the cell and blocks the function of this and other proteins."  Tykerb will be distributed by GlaxoSmithKline.

Commenting on the new drug, Steven Galson, Director of FDA's Center for Drug Evaluation and Research, stated, "New targeted therapies such as Tykerb are helping expand options for patients." 

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Breast cancer survivors were given new hope last week when the FDA cleared for marketing the MammaPrint test, a test developed by Agendia, a lab in the Netherlands, that predicts the likelihood of distant metastatic breast cancer recurrence within five to ten years.   Because cancer recurrence is partially attributable to the behavior of genes, the test profiles genetic activity and, according to the FDA, the resulting analysis positively assists doctors in making treatment decisions and formulating a plan of care for their patients.  The product has been on the market in the Netherlands for about two years. 

Data submitted by Agendia that assessed the tumors of 302 node negative early stage (stage I and II) breast cancer patients under age 61 confirmed that the test effectively predicted time to distant metastasis.  Within the next 60 days, the FDA plans to publish a special controls guidance document describing the data that supports genetic profiling claims.

 

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Last week, the FDA responded to the Institute of Medicine's 2006 report entitled "The Future of Drug Safety:  Promoting and Protecting the Health of the Public."  In the FDA's press release, the FDA noted plans to increase drug safety by taking actions in support of the following (as taken directly from the press release):

• Strengthening the science that supports the FDA's medical product safety system at every stage of the product life cycle from pre-market testing and development through post-market surveillance and risk management;
  
  
  • FDA initiatives include developing new scientific approaches to detecting, understanding, predicting, and preventing adverse events, developing and incorporating new quantitative tools in the assessment of benefit and risk, and conducting a pilot program to review the safety profiles of certain newly approved drugs on a regularly scheduled basis.

• Improving communication and information flow among all stakeholders engaged in promoting the safe use of medical products; and

• FDA initiatives include the establishment of an advisory committee to provide input to improve the agency's risk communication policies and practices, conducting a comprehensive review of current public communication tools and developing a comprehensive risk communication strategic plan.

• Improving operations and management to ensure implementation of the review, analysis, consultation, and communication processes needed to strengthen the U.S. drug safety system.

• FDA initiatives include engaging external management consultants to help the Center for Drug Evaluation and Research (CDER) develop a comprehensive strategy for improving CDER's organizational culture, and making specific organizational and management changes to increase communications among review and safety staff.

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The United Press International article "Analysis: FDA Approving More Drugs" reports that, although the FDA "has been picking up its pace for approving new drugs," a factor that could bode well for the pharmaceutical industry in 2007, tighter controls launched next year by the Democratic majority could slow the drug approval process.  Thus far, October has been the busiest month of 2006, with fifteen new drug application approvals and five new molecular entity approvals.   

Despite the shift in power, some projections still estimate that the industry could see five to six percent growth, but new product launches may remain constant.  The article also speculates that health information technology companies will benefit from stronger regulatory measures.

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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.

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