INFECTIOUS DISEASE  ^{BACK TO TOP}

TARGET HEALTH has been actively following the AIDS conference in Geneva and the following summarizes the profound impact on both the developed and developing countries.  Tragically, this disease is completely avoidable through the same solid public health measures as was done for the eradication of malaria in the US.  While there is clearly a specific need to treat those currently infected with HIV, there will be no true solution until there is a war to stop transmission.  TARGET HEALTH has worked closely with Dr. Nick Plotnikoff in his attempts to bring to market an immune modulator for AIDS and other viral diseases.   

The 12th World AIDS Conference was held this past week in Geneva.  Pleas for national leaders to carry out strong prevention programs to stop the global epidemic of AIDS was a major theme.  More than 10 million people have become infected with HIV since the last AIDS conference in Vancouver in 1996, about half are under age 25.  Sixteen thousand new infections occur daily.  In a new attempt to slow the transmission of AIDS from mothers to their babies, the United Nations is launching a pilot program to treat 30,000 pregnant women infected with HIV.  Treatment will occur primarily in Africa where 21 million of the 30 million HIV infected people live.  The AIDS program has negotiated with AZT's manufacturer, GLAXO WELLCOME PLC, for a substantial reduction in the cost of the drug: $50 for the course of AZT and $20 for testing. A short course of treatment typically costs $800. Participants will receive free AZT starting at the 36th week of pregnancy and during labor.  Each year an estimated 2 million HIV-infected women worldwide become pregnant and about 680,000 babies were born with AIDS last year.  A third of HIV transmissions from mother to child in developing countries are passed via nursing.

AIDS destroys the immune system largely by the virus's destruction of CD-4 blood cells. When these cells drop to low levels, an individual's risk of developing a number of unusual infections as complications of AIDS increases dramatically.  Among such infections are pneumocystis pneumonia and toxoplasmosis.

 APPROVALS ^{BACK TO TOP}

TARGET HEALTH is not only active in the drug area, but also in the device area with two IDE and three 510(k) approvals.  In devices, TARGET HEALTH can manage the FDA interactions, make all submissions and manage the clinical and PMA processes.

Migraine

MERCK & CO. has received FDA approval for their oral anti-migraine drug Maxalt.   Maxalt is a 5HT-1 agonist and joins Imitrex (GLAXO WELLCOME PLC) and Zomig (ZENECA GROUP PLC) in the Rx market. Excedrin (BRISTOL MYERS SQUIBB) has recently received OTC approval.  Imitrex sold $1.1 billion last year.

It is estimated that 23 million people suffer from migraines in the US alone. With MERCK's patents for Mevacor and Zocor expiring in 2000 and 2001, respectively, new drugs are desperately needed.  We are sure that our Scientific Advisor, Al Alberts, formerly of MERCK, will be sad to see his creations "Go Generic".  Both MERCK and ZENECA are pushing a more rapid time of onset, while GLAXO WELLCOME is trying to keep up with the competition by developing an Imitrex nasal spray.

Mammograms

The FDA has approved a new computer system that will call attention to parts of a mammogram image that are suspicious.  The device has the potential to reduce the number of women who have delayed diagnosis of breast cancer due to missed abnormalities in screening mammograms.  The device, the M1000 ImageChecker, is made by R2 TECHNOLOGY, INC. of Los Altos, CA.  Studies showed improved detection rates from approximately 80 out of 100 cancers to almost 88 out of 100.

ImageChecker scans mammograms with a laser beam to convert the image into a digital signal.  The signal is processed in a high-speed computer to identify possible signs of cancer.  Video monitors display the mammographic images, with markers highlighting suspicious areas.  With the ImageChecker, the radiologist first reviews the mammograms in the conventional manner, then activates ImageChecker and looks at the suspicious areas highlighted on the monitors.  In the US, for every 80 cancers currently detected through routine mammogram screening of healthy women, an estimated 20 additional cancers are missed and not found until later.  Of those missed, about half have cancerous features that are simply overlooked; the other half have cancerous features but look benign.  FDA's approval of ImageChecker was based on data from clinical studies in which more than 40,000 mammograms were reviewed.

TARGET HEALTH is very active with open IND's and IDE's in the area of Women's Health.  An NDA is forthcoming in 3Q 1998.

  INDUSTRY NEWS^{BACK TO TOP}

TARGET HEALTH works closely with the best and most savvy patent and regulatory lawyers at all stages of drug and device development.  TARGET HEALTH is currently consulting on the use of an approved device with a novel treatment for prostate cancer as well as on IND requirements in gene therapy.

Two Boston institutions have been issued three patents for technology which allows the insertion of human cells into the body to grow into new organs. ADVANCED TISSUE SCIENCES (ATS), located in La Jolla, CA,  has licensed the patents and is preparing for clinical trials.

The patents describe a process of growing human cells, initially in vitro, on a three-dimensional, biocompatible and biodegradable scaffolding built from ordinary surgical suture material.  ATS is currently using polyglycolic acid because the rate at which it dissolves can be controlled.  The crux of the discovery is placing the cells in the right three-dimensional orientation and the right distance apart so they are able to get oxygen and nutrients.  Once the cells are seeded on the scaffolding, the tiny mesh structure is implanted into the body where replacement tissue is needed.  Hopefully, it then incubates and grows into tissue, replacing diseased tissue until it is contiguous with and indistinguishable from the patient's own healthy tissue.

ATS has conducted animal trials to grow pancreas, gastrointestinal tracts, bone, ligaments, skeletal muscle, cardiac muscle and livers. The company hopes to begin clinical trials with human cells soon, and ultimately to create a technology that will allow for implantation of cells that will grow into parts of or whole new organs.  Along with bio and genetic engineering, cell transfer technology could change medicine as we know it and potentially slow the disease and aging processes.

Joseph P. Vacanti, a pediatric surgeon at Children's Hospital of Boston, and Robert S. Langer, a polymer chemist at MIT, won patents 5,759,830, 5,770,193, and 5,770,417.   Patents are available by number for $3 from the Patent and Trademark Office, Washington, D.C. 20231.

 FDA ^{BACK TO TOP}

TARGET HEALTH excels in Regulatory Affairs and works closely with many of its clients and FDA.  Each week highlights of what is going on at FDA is shared to assure that new information is expeditiously made available.  For additional information, please contact Dr. Jules T. Mitchel at TARGET HEALTH.

Revised Labeling - Propulsid

The word is that President Clinton uses Propulsid to treat his acid stomach. We hope that he didn't need any on his apparently successful trip to China.

The FDA is advising doctors about new warnings of cardiac problems associated with the drug Propulsid (cisapride), a treatment for nighttime heartburn. FDA's warning is being issued in conjunction with a "Dear Healthcare Professionals letter" from the drug's sponsor, JANSSEN PHARMACEUTICALS of Titusville, NJ.  The drug's labeling has been revised to include new information about the cardiac risks associated with the drug and to recommend that other therapies for heartburn generally be used before Propulsid.  These actions were prompted by reports of serious adverse reactions -- including heart rhythm disorders and deaths associated mostly with the use of the drug in people who were taking certain other medications or who had particular underlying medical conditions.  From 1993 to 1998, while there were 38 reports of deaths in the U.S., the FDA cannot directly link reported deaths to the drug.

The "Dear Healthcare Professionals letter" and revised labeling for Propulsid emphasize that the drug should not be used in patients taking certain antibiotics, antidepressants, antifungals, protease inhibitors, or various other drugs.  The strengthened warnings also contraindicate the drug's use in patients with certain disorders--such as congestive heart failure, multiple organ failure, chronic obstructive pulmonary disease which causes serious respiratory problems, and advanced cancer.  Propulsid should also not be administered to patients with electrolyte disorders (hypokalemia or hypomagnesemia).  These include patients with severe dehydration, vomiting, diarrhea, or malnutrition, or those taking potassium-wasting diuretics and/or insulin in acute settings, or who might experience rapid reduction of plasma potassium.  Furthermore, doctors are being advised that Propulsid should usually be used in patients who have not responded adequately to lifestyle modifications or other drugs for treating nighttime heartburn due to gastroesophageal reflux disease.

Propulsid was approved by the FDA in tablet form in 1993, and in suspension form in 1995.  Health care providers should report any adverse events related to Propulsid to JANSSEN PHARMACEUTICALS (800-526-7736) or to FDA by telephone (800-332-1088) or by fax (800-332-0178).

Voluntary Recall - Weight Loss Device

FDA is alerting consumers to a nationwide recall of an electrical weight loss pad produced by TV Store Corp./Body Fitness Inc. The firm has received complaints that indicate that its Moulding Body Electrical Body Belts, also called the Personal Electro-Sauna, is hazardous and has caused skin burns and fires.  The product resembles a heating pad and can be wrapped around the waist, thighs or arms.  It is not approved by the FDA.  Consumers who have purchased Moulding Body should stop using the product at once.  TV Store is currently conducting a voluntary recall of the product. The product was sold nationwide in the United States, Puerto Rico and Canada.  Questions about TV Store's recall can be addressed to the firm at 1-800-366-9940, Monday through Friday, 9 a.m. to 1 p.m., EST.

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