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FDA's Final Rule Forces the Pharma Industry to Change It's Clinical Trial Culture

Genentech's sprawling campus overlooking San Francisco Bay seems serene on the surface, but internally, the company resonates with energy.

London-The National Institute of Clinical Excellence (NICE) has decided that Roche's Xenical (orlistat) should be available from the National Health Service for managing obesity and its related problems, but it should not be viewed as a slimming pill.

How to Hire the Right Reps, Train Them to Excel, and Retain Them for the Long Run

Although industry seeks to protect its rights, the only long-term solution is working with the international community to address the AIDS crisis and other serious health problems.

What the WLF decision means for pharmaceutical reps.

It seems nothing short of amazing to me that the vast majority of pharmaceutical reps bypass what is surely the most potent sales tool that exists. Before I became a provider 22 years ago, I was involved in sales. It was then that I realized that sales are greatly influenced by the nature and quality of the relationships between salespeople and their customers. Failure on the part of pharmaceutical representatives to develop good, strong relationships most often leads to poor prescribing habits on the part of the provider.

In an independent analysis of prescription drug treatments for hypertension, the Evanston, IL-based health data company Solucient found that 49% of patients who were started on an ACE inhibitor had no prior history of hypertension treatment during the previous 12 months. Moreover, three in four of those patients also had no history of heart failure or diabetes, two conditions that indicate ACE inhibitors as a first-line hypertension therapy.

According to "Outlook 2001," a report released by the Boston-based Tufts Center for the Study of Drug Development, the United States today spends nearly three times as much on physician services as it does for prescription drugs, and over four times as much as it does for hospital care. Although prescription drugs, as a share of total U.S. healthcare spending, increased from 5.5% a decade ago to 8.5% today, hospital expenditures declined from nearly 37% to 33% during the same time period, while spending on physician services remained nearly constant.

More than 20 new drugs were added to the Fall 2000 edition of Newtown, PA-based Scott-Levin's Managed Care Formulary Drug Audit. Betapace AF™ (sotalol HCl), a cardiovascular therapy manufactured by Berlex Laboratories Inc., Montville, NJ, was the new product with the highest level of formulary acceptance, according to the audit.

President Bush has sent his temporary prescription drug proposal for low-income families - called "An Immediate Helping Hand" - to Congress. The plan would provide block grants to states to cover drug costs for seniors 65 and older who have incomes of up to $11,600, and up to half the drug costs of seniors with incomes of up to $15,000. The plan would also cover drug costs for any Medicare patient, regardless of income, if his or her yearly drug costs exceed $6,000.

For the past four years, the volume of healthcare services mergers and acquisitions has always slowed in the fourth quarter. While the fourth quarter of 2000 was no exception, the size of the decline was larger than usual and the number of transactions fell below 100, hitting a seven-year low, according to New Canaan, CT-based Irving Levin Associates Inc. In its fourth quarter 2000 Healthcare M&A Report, the firm points out that there were just 90 healthcare services mergers and acquisitions announced, representing a 30% decline from the third quarter and a 43% plunge from the fourth quarter of 1999.

President Bush and Sen. John McCain (R-AZ) are set to battle over McCain's "Bipartisan Patient Protection Act of 2001," a patients' rights proposal he has introduced with Senators John Edwards (D-NC), Ted Kennedy (D-MA), Lincoln Chafee (R-RI), Tom Harkin (D-IA) and Bob Graham (D-FL). The proposal would:

Antidepressants in the SSRI/SNRI class were the subject of the most pharmaceutical industry details and events during the third quarter of 2000, according to an audit by Newtown, PA-based Scott-Levin.

Health and Human Services Secretary Donna E. Shalala released the nation's first standards for protecting the privacy of Americans' personal health records.

A new report by New York-based Datamonitor reveals that both traditional and innovative therapy opportunities will exist for breast cancer in the near future.

No one wants to hang around people who are sad all the time, or who have a chip on their shoulder.

Prioritize, manage and monitor daily activities.

Finding the right physician is the "best advice" irritable bowel syndrome patients would give to fellow IBS sufferers, according to Andover, MA-based DrugVoice's new 200-plus-question survey of over 1,700 IBS patients.

An updated version of the "Guidelines for the Use of Antiretroviral Agents in HIV-Infected Adults and Adolescents" has been released by the Panel on Clinical Practices for the Treatment of HIV Infection, a joint effort of the Department of Health and Human Services and the Menlo Park, CA-based Henry J. Kaiser Family Foundation.

Fair price comparisons between pharmaceuticals sold in foreign countries and those sold in the United States may not be possible, according to a new report from the Federal Trade Commission. The study, conducted at the request of the House Ways and Means Committee, reveals how drug prices are established, the role of compulsory licensing in setting prices and a description of the costs associated with the development of prescription drugs in Canada, France, Germany, Italy, Japan, Mexico, Russia and the United Kingdom.

America's registered nurses feel that deteriorating working conditions have led to a decline in the quality of nursing care, according to a national survey released by the Washington-based American Nurses Association.

According to a recently released survey by the Bethesda, MD-based American Society of Health-System Pharmacists, over half (51%) of American adults take two or more medications each day. In addition, almost half (46%) of Americans take at least one prescription medicine every day, while more than a quarter (28%) take multiple prescription medications daily. The survey of 1,000 Americans focused on consumers' use of prescription and nonprescription medications, including herbal supplements and vitamins.

A General Accounting Office examination of prescription drugs withdrawn from the U.S. market determined that most posed more health risks to women than to men. According to the GAO, ten prescription drugs have been withdrawn since January 1997, eight of which caused more adverse events in women; four of the drugs' users were mostly women, and four were widely prescribed to both men and women.

An article in the New England Journal of Medicine (vol. 344, no. 3) asserts that the increased penetration of managed care organizations actually increases the amount of time patients spend with their doctors. The article debunks most physicians' perception that managed care limits the time they have to spend with their patients.

London, UK-Changes to the law on human embryo research could herald a new era for UK biotech research. The government feared its proposals to allow the cloning of embryos as sources for stem cells for research would be thrown out by the House of Lords-where a powerful body of opinion holds that they represent a slippery slope toward reproductive cloning-but the proposals passed by a surprisingly large majority.

Industry Must Set Product Prices That Ensure Reasonable Profit - and Minimize Political Fallout

The number of pharmaceuticals in development recently mushroomed, and the complexity of trials is increasing. Amgen has reduced its cycle times but still wants to improve efficiency and cost effectiveness as it enlarges its pipeline, presenting tough new challenges in clinical research.

Sodertalje, Sweden-After two consecutive years of robust postmerger growth, AstraZeneca is facing a tough 2001. The company recorded a 16 percent increase in pretax profits for 2000, but CEO Tom McKillop advises that this year}s growth will be in the 5}6 percent range when Losec/Prilosec (omeprazole)-the world}s best-selling medicine-goes off patent and the US launch of its successor Nexium (esomeprazole) is delayed.

A cure for cancer is the Holy Grail of modern medicine--long sought but seemingly unattainable. Because cancer cells are not foreign, easily identifiable invaders, but native parts of the bodies in which they live, neither the immune system nor chemical compounds have been able to accurately target and eliminate them from healthy tissue.