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The past few years have seen a steady increase in new medicines being discovered and developed in the United States and a decrease in those from Europe, where it takes much longer for new medicines to become available to patients. In some cases, it takes medicines three or four years from their approval date to reach the market in all European Union member states. So, in March 2001, the European Commission appointed a high-level group to address those issues on a Europe-wide basis, involving all the different member states and stakeholders.

The National Institute of Health Care Management made headlines with its report on double-digit increases (17 percent) in retail spending on medicines in 2001. The total reached $155 billion last year, almost double the $80 billion spent in 1997, according to the study, "Another Year of Escalating Costs." PhRMA president Alan Holmer said the increase is a good thing, signifying that more people who need medicines for chronic conditions are being treated and thereby avoiding more expensive medical procedures.

African-American physicians regard direct-to-consumer advertising of prescription medicines as one way to educate minority patients about needed treatment and healthcare options, according to a survey conducted by the National Medical Association (NMA). Almost all of the 900 physicians answering the questionnaire reported that DTC advertising has prompted patients to ask questions, and one-third acknowledged that they feel additional pressure to justify their prescribing decisions. But almost half (48 percent) said that such promotion increased communications between physicians and patients.

A flood of counterfeit medications into the Nigerian market is causing great concern among the nation's regulatory authorities, according to a British Medical Journal report. Many fakes may contain a small amount of the active ingredient but not enough to make them therapeutically useful. Under-strength antibiotics represent a significant public health problem, as the inadvertent administration of them can lead to bacterial resistance.

Among the dozens of initiatives in Washington affecting the pharma industry, one common thread is the growing movement to control accelerating expenditures for prescription medicines.

Science deserves all the credit it gets, and more, for driving this industry. Still, no science succeeds without a certain application of what we broadly call art. Inside the scientific discipline, many arts apply-the art of experiment, the art of planning, and the art of free association among them.

Because of the European Union's country-by-country drug price controls, enterprising wholesalers often buy prescription drugs in nations that keep prices low and resell them in countries that allow higher prices. Sanofi-Synthelabo's Plavix costs $55 in France but is resold for $79 in England. That long-standing practice, known as parallel trade, costs the pharma industry an estimated $3 billion in lost profits each year.

As of 2000, there were approximately 7,500 clinical projects in the R&D pipeline worldwide, according to IMS Health. By 2003, analysts estimate the total number will grow to more than 10,000 clinical projects worldwide. CenterWatch reports that for each new drug application to FDA, pharma companies must conduct an average of 68 studies (Phases I-III) that need a total of 4,300 volunteers. With the expected increase in global R&D projects over the next year, the number of patients needed for enrollment is expected to grow by 15 percent annually.

The returns are in, and they are not pretty. Janus Funds' billion-dollar investment in WebMD in 2000 now has a net value of roughly ten cents on the dollar, and many observers see WebMD as a winner in their space-whatever that space is now.

The European Medicines Evaluation Agency (EMEA) has promised to get tough with pharma companies if they fail to follow its rules for reporting product side effects. It may resort to naming and shaming those that do not comply and could even prosecute offenders.

Kiln, a Lloyds of London underwriter, has come up with a novel way for pharma companies to mitigate the risk of patent challenges: insurance. Kiln created a policy for a big pharma company covering a number of patents and trademarks the company considers essential for its future profitability.

Clinical trials are complex, time consuming, and data intensive. Yet pharma remains one of the few industries that is still largely paper driven.

As the fanfare over the sequencing of the human genome fades, the spotlight turns to the "shovel and pans" companies offering the tools investors are betting on to make "gene to drug" a reality.

Products in Trouble

After three successive blows, Wall Street analysts say BMS, the fifth largest global pharma company, could be a takeover target. First came FDA's refusal to review the data for Erbitux (IMS 255), BMS and ImClone's joint cancer treatment candidate in which BMS has invested more than a billion dollars. Two months later, the company announced that next year's earnings might be only half that of this year. Disappointed stockholders unloaded in droves, driving the price down nearly 15 percent. And to top it off, the board of directors has put CEO Peter Dolan on notice: one more stumble and he's

Washington DC-In addition to launching an ad campaign backing adoption of a Medicare drug benefit, PhRMA is expanding its state lobbying efforts to block local prior authorization requirements. As more states face huge shortfalls in Medicaid budgets because of declining revenues and rising healthcare costs, they seek to cut spending on prescriptions. That means more restricted formularies and rebate requirements, with prior authorization imposed on doctors to limit prescribing of therapies that fail to offer sufficiently attractive deals.

Canberra, Australia-The Australian Pharmaceutical Manufacturers' Association has denounced calls from the country's media and some of its doctors to drastically curtail drug promotion. APMA chief executive Alan Evans says any such move would severely affect the healthcare of millions of people in Australia and could even result in premature death.

London, UK - According to the magazine Health Which?, patients fail to receive full information about the efficacy and safety of antidepressants, including the risks of withdrawal and suicidal behavior.

More than a fifth of the people in the European Union are age 16 or under, yet at least half of the medicines in use there have not been tested on children. As a result, the region suffers from a lack of information about the safety and efficacy of pediatric medicines and of off-label pediatric use that medical experts say could cause adverse effects and even death.

GSK Faces Bribe Charges, Changing of the Guard

As a chemist, a vice-president, and just about everything in between, Sarah Harrison has spent 25 years delivering business excellence and predicting the impact of radical changes in the healthcare environment. Now she leads AstraZeneca in its own multi-faceted transformation.

New markets are a pharmaceutical company's dream. And China, with a population of 1.3 billion-and new membership in the World Trade organization-could be the pharma industry's dream come true. The country's projected growth rate of 1.1 percent per year, which will increase its pharma market by at least $50 million annually, in addition to an increasingly prosperous population with a greater awareness of health-related issues, make the market extremely attractive. (See "People Power,")

Capetown-In March, ruling on a case initiated by the Treatment Action Campaign, Save Our Babies, and the Children's Rights Centre, Judge Chris Botha ordered the South African government to provide the anti-retroviral nevirapine to all HIV-positive pregnant women.

After months of stalemate between the White House and Senate democrats over the appointment of a new FDA commissioner, Health and Human Services secretary Tommy Thompson took a shortcut February 26 and named Lester Crawford deputy commissioner. The move allowed Crawford to start work at FDA immediately, skipping the lengthy Senate confirmation process.

Ed Calesa knows women-or rather, he understands the female market. After starting his career as marketing research manager for Roche, he co-founded Health Learning Systems in 1971 and pioneered the use of continuing medical education as part of the healthcare promotional mix. There he developed and implemented two of the earliest and most successful initiatives targeting female baby boomers. Launched during the drive for women's liberation in the swingin' seventies, Calesa's campaigns helped open a dialogue between opinion leaders and women, addressing contraception and the use of formula for newborns. During nearly 20 years in that position, he gained an

Eli Lilly recently joined the growing list of pharma companies offering discount card programs for Medicare beneficiaries in an effort to "do something now" to help low-income seniors afford medicines. Although Lilly chairman Sidney Taurel voiced support for a broader drug benefit for the elderly-as do his pharma colleagues-he described the LillyAnswers program as "quick relief" while the Medicare-reform debate continues.

A new report by Médecins Sans Frontières (MSF) scotches the myth that the most effective forms of malaria treatment are too expensive for East African countries.

The pharmaceutical industry stands in the crosshairs of federal and state law enforcement agencies. It is not being targeted by FDA for regulatory violations, as one would expect, but by many other government agencies

As proposals proliferate to establish a Medicare pharmacy benefit, the cost estimates continue to soar. The White House began in February by proposing to spend a measly $190 billion over ten years.

Brussels, Belgium-Tackling communicable diseases such as malaria and tuberculosis and making pregnancy and childbirth safer are priorities for the restructured Afghan health ministry, according to World Health Organization officials.