Worries of aging mark opportunity in biotech

As Americans grow older, they worry about what might happen to them - and therein lies a great market for the biotechnology industry.

If cancer, heart disease, stroke and all the other conditions whose risks are associated with getting older are included, products to help older people could account for 80% of an estimated $50 billion biotechnology market by the year 2000, said Daniel Perry, executive director of the Alliance for Aging Research. Illnesses of the old now cost the country $573 billion a year in medical care, Perry added.

More than 100 biotech companies are working on products to help aging Americans retain physical and mental health, said Carl Feldbaum, president of the Biotechnology Industry Organization (BIO), according to a report in BBI's sister publication, BioWorld Today.

A poll sponsored by BIO found that the major worry Americans have about getting older is maintaining good health. Of the 800 people in the poll, 49% listed that as their principal concern - a figure that rose to 59% for persons 45 and over.

At the top of the list of health concerns was worry about losing mental capacity or growing senile, listed by 36% of the participants.

More than a half-dozen biotech companies have products aimed at maintaining neurological health in or near clinical trials, said John Farah Jr., director of scientific affairs at Cephalon Inc. (West Chester, Pennsylvania). All those products are aimed at specific neurological disorders, but those are believed to be exaggerated versions of the decline of mental power that can occur with age.

Regulation of borderline devices

Increasingly, combined products which incorporate characteristics and properties both of medical devices and pharmaceuticals are being developed and launched into the European market. Some of these products which are regulated as drug delivery devices are subject to the Medical Device Directive (MDD). The demarcation guidance list issued by the European Commission includes as examples:

* Iontophoresis devices

* Port systems

* Nebulizers

* Implantable infusion pumps

* Jet injector syringes

In the case of insulin injection kits, the insulin pen is subject to the MDD, whereas the insulin cartridge is a medicinal product. However, where a device is designed for use with a specific drug with, for instance, standardized metering or dose controls - e.g., some inhalation devices - decisions on assessment either by the Medicines Control Agency, national Competent Authorities, or by Notified Bodies, will have to be made on a case-by-case basis.

On the other hand, where the device and the drug are together an integral product, such as prefilled syringes, transdermal patches or orthopedic implants incorporating antibiotics, the combined product will be regulated by the Medicines Control Agency, although device-related features and specifications will still have to comply with the MDD.

The European Commission soon will have a guidance document available that should provide much-needed clarification in a growing medical device sector.

Jeffords to chair key senate committee

Sen. James Jeffords, a moderate Republican from Vermont, reportedly will assume chairmanship of the Senate Labor and Human Resources Committee when the 105th Congress swings into action this month. In that position, Jeffords will oversee senate FDA reform efforts, as well as conduct confirmation hearings for the Clinton administration's nominee to replace outgoing FDA Commissioner David Kessler, who will leave the regulatory agency as soon as a successor is named.

More cuts to come in Germany

A new report, "Health in Germany - Cost factors and Growth areas," is from a committee appointed by Horst Seehofer, federal minister of health. The committee reports on projected effects of Germany's aging population and forecasts resultant increased incidences of lung diseases, cardiovascular illnesses, prostate-related illnesses and some forms of cancer.

The report also says that a significant proportion of diagnostic procedures carried out by specialists in Germany are unnecessary or of unproven benefit. Areas highlighted in the report include arthroscopies, X-ray examinations, electrocardiography and bone densitometry checks for osteoporosis. This is an interim report, with the full report due in mid-1997, but Seehofer already is saying that the report confirms his view that further significant savings in health care are possible.

CLARIFICATION

A report in the November issue incorrectly indicated that HK Medical Technologies (San Antonio, Texas) had received FDA marketing approval and the European CE mark for its Autocath 100 intra-urethral insert. HK Medical received an IDE (investigative device exemption from the FDA in November 1995, and started U.S. clinicals in April. Company officials said they expected CE Mark approval by the end of December.

COPYRIGHT 1997 A Thomson Healthcare Company
COPYRIGHT 2004 Gale Group