According to an article in the NY Times by Alex Berenson, the drug industry's image problems are beginning to hurt pharmaceutical companies where it matters most - at the bottom line.
A year after Merck's withdrawal of its arthritis medicine Vioxx led to an industrywide credibility crisis, the Food and Drug Administration is blocking new medicines that might previously have passed muster. Doctors are writing fewer prescriptions for antidepressants and other drugs whose safety has been challenged, like hormone replacement therapies for women in menopause.
Meanwhile, insurers and some states are taking advantage of the backlash against the industry to try shifting patients to older, generic drugs, arguing that they work as well as newer and more expensive branded medicines. Overall, prescriptions continue to rise slightly, but an increasing share of prescriptions are going to generic drugs. Also, consumers seem to be less responsive to aggressive drug marketing.
"A lot of the demand that the industry has created over the years has been through promotion, and for that promotion to be effective, there has to be trust," said Richard Evans, an analyst covering drug stocks at Sanford C. Bernstein and Company. "That trust has been lost."
In the background, new competitors are forcing the old-line drug giants to struggle to keep pace. Biotechnology companies like Genentech are taking the lead in finding new treatments for cancer, a promising and lucrative field.
Executives of the major drug companies say they expect public scrutiny in the wake of problems with Vioxx and other drugs. But they say they are concerned that consumer mistrust has led to unrealistic expectations about drug safety and risks, stunting the development of new medicines.
"I think there is an overall unreasonable expectation right now that there is such a thing as a risk-free drug," said Sidney Taurel, chief executive of Eli Lilly & Company.
The major drug makers remain highly profitable. But at some, including Pfizer and Merck, the largest and third-largest American companies in terms of revenue, sales are stagnant and profits are falling, leading to layoffs and - for the first time in years - cuts in research budgets.
In the third quarter, United States sales of prescription drugs fell 3 percent at Bristol-Myers Squibb, 4.5 percent at Johnson & Johnson, and 15 percent at Pfizer. Merck said its overall revenues fell 2 percent despite favorable foreign exchange trends.
The companies are reticent concerning details of layoffs, but both Pfizer and Merck have said they are cutting workers. Even Eli Lilly, where United States sales rose about 5 percent in the third quarter, said it has cut about 1,600 employees - almost 4 percent of its work force - so far this year.
No one expects a quick end to the crunch, because several top-selling drugs will lose American patent protection by early 2007. They include Norvasc, a blood pressure medicine from Pfizer, and Zocor and Pravachol, cholesterol drugs from Merck and Bristol-Myers Squibb. Together, those three drugs have almost $10 billion in annual United States sales.
The drug industry, which is dominated by companies based in this country, is hardly in a full-blown crisis, and layoffs are occurring mainly on the margins of its work force. Pfizer alone will make about $8 billion in profit this year, on sales of about $51 billion, and invest more than $7 billion in research and development - although the company's research spending fell 6 percent in the third quarter of 2005 compared with the same period in 2004, and Pfizer expects it to stay flat or decline in the coming years. Overall, the industry spends more than $30 billion annually on research and development.
But for the companies, and for patients who are counting on industry research to produce new treatments for diseases like rheumatoid arthritis and diabetes, these are trying times. Wall Street has also taken notice of the industry's woes. Shares of Pfizer are near their lowest levels since 1997, closing Friday at $22.43, and a broad index of drug stocks has fallen 25 percent in five years. In contrast, shares of biotechnology companies are soaring.
Without new drugs to promote as patents expire, and with the bar set so high by the blockbusters of the last decade, the old-line companies have depended on stopgap measures to protect sales, like reformulating existing drugs so they can be taken once a week instead of once daily. At the same time, they have used consumer advertising to drive patient demand. But those strategies appear to be losing their effectiveness, as consumers become more skeptical and insurers rebel against high prices for drugs that are not therapeutic breakthroughs.
For example, in June Pfizer began selling Zmax, an antibiotic that contains the same active medicine as Zithromax, which was introduced in 1992 and lost its patent protection last week. Pfizer calls Zmax a major advance because it is designed to be taken in a single dose, while Zithromax must be taken for up to five days. Both drugs cost about $52 for a course of treatment, according to Pfizer.
However, clinical trials show that the convenience of Zmax comes with a side effect: it causes diarrhea in 12 percent of patients, compared with 5 percent for Zithromax.
"Is the public more cynical? Yes," said Dr. John LaMattina, Pfizer's president of global research. "There's a perception that we don't bring much to the party."