Drug Companies Increase Prices in Face of Change

Drug Makers Raising Prices Before Reform - NYTimes.com

Even as drug makers promise to support Washington’s health care overhaul by shaving $8 billion a year off the nation’s drug costs after the legislation takes effect, the industry has been raising its prices at the fastest rate in years.
In the last year, the industry has raised the wholesale prices of brand-name prescription drugs by about 9 percent, according to industry analysts. That will add more than $10 billion to the nation’s drug bill, which is on track to exceed $300 billion this year. By at least one analysis, it is the highest annual rate of inflation for drug prices since 1992.

Medicine’s Elusive Goal: A Safe Weight-Loss Drug

Americans spent an estimated $59 billion last year fighting fat — on weight-loss programs, special foods, low-calorie soft drinks, appetite suppressants, gym memberships, diet books, exercise videos, even stomach-clamping surgery.

But less than 1 percent of that sum, as estimated by the research firm Marketdata Enterprises, was spent on prescription drugs. Despite years of research effort — and haunted by diet drugs that proved dangerous, like fen-phen in the 1990s — the pharmaceutical industry has not made meaningful progress in combating obesity, one of the nation’s biggest and costliest health problems.
Now, though, three small California companies hope to succeed where many bigger players have failed. The companies — Arena Pharmaceuticals, Orexigen Therapeutics and Vivus — plan to apply in the coming months for regulatory approval of anti-obesity drugs that could reach the market in late 2010 or in 2011.

Psychiatric Group Faces Scrutiny Over Drug Industry Ties

Commercial arrangements are rampant throughout medicine. In the past two decades, drug and device makers have paid tens of thousands of doctors and researchers of all specialties. Worried that this money could taint doctors’ research plans or clinical judgment, government agencies, medical journals and universities have been forced to look more closely at deal details.
In psychiatry, Mr. Grassley has found an orchard of low-hanging fruit. As a group, psychiatrists earn less in base salary than any other specialists, according to a nationwide survey by the Medical Group Management Association. In 2007, median compensation for psychiatrists was $198,653, less than half of the $464,420 earned by diagnostic radiologists and barely more than the $190,547 earned by doctors practicing internal medicine. But many psychiatrists supplement this income with consulting arrangements with drug makers, traveling the country to give dinner talks about drugs to other doctors for fees generally ranging from $750 to $3,500 per event, for instance.

How much sexual innuendo can an advertiser pack into 15 seconds?

Pfizer has always straddled a line marketing Viagra, insisting that the drug treats a serious medical condition, impotence, and deserves insurance coverage, while promoting the drug with wink-and-a-nod ads that have irritated regulators. In 2004, the Food and Drug Administration told the company to stop running ads that included the lines, “Remember that guy who used to be called ‘Wild Thing’? The guy who wanted to spend the entire honeymoon indoors?”
The ads come as Viagra is losing market share to other impotence drugs. Last year, Pfizer’s Viagra sales totaled $1.7 billion, including $800 million in the United States.

The Case for Another Drug War, Against Pharmaceutical Marketers’ Dirty Tactics

Our Daily Meds begins by illustrating the established drug-company practices that have led to this sorry juncture. There is the rigging of studies, so that to be deemed “effective” a drug need only perform better than a sugar pill. There are the promotional strategies that evade the need for F.D.A. warnings by, say, planting logos for the sexual enhancement drug Viagra and the antidepressant Wellbutrin on Nascar vehicles. There is the co-option of doctors and university researchers by aggressive, payola-dispensing drug company representatives. . . . But she moves to weightier matters in assessing the directions in which heavy drug dependence is leading Americans. First of all there are the business strategies that have created illnesses out of what used to be facts of life, labeled them as syndromes, and have hooked customers into long-term use of medication to cure them. . . . Second, there are the economics of creating chronic consumers for marginally necessary drugs. . . . Irate as she is that in a period (1980-2003) when Americans doubled what they spent on cars they increased their spending on prescription drugs by 17 times, Ms. Petersen steps back to consider the long-term consequences of this shift in consumption. She notes that the first generation of children raised in front of ubiquitous, sunny drug-company advertisements (which became legal in 1997) has acquired the notions that prescription pills fix everything, and that they are less dangerous than street drugs. Then, looking to the elderly, she points out that increasing numbers of drugs are accumulating in these patients, with little regard for the consequences.

Lilly Considers $1 Billion Fine to Settle Case

Eli Lilly and federal prosecutors are discussing a settlement of a civil and criminal investigation into the company’s marketing of the antipsychotic drug Zyprexa that could result in Lilly’s paying more than $1 billion to federal and state governments. If a deal is reached, the fine would be the largest ever paid by a drug company for breaking the federal laws that govern how drug makers can promote their medicines. . . . Zyprexa has serious side effects and is approved only to treat people with schizophrenia and severe bipolar disorder. But documents from Eli Lilly show that from 2000 to 2003 the company encouraged doctors to prescribe Zyprexa to people with age-related dementia, as well as people with mild bipolar disorder who had previously had a diagnosis of depression. Although doctors can prescribe drugs for any use once they are on the market, it is illegal for drug makers to promote their medicines for any uses not formally approved by the Food and Drug Administration.

List of problem prescription drugs is growing

An increasing number of prescription drugs - some that have been widely promoted through seductive advertising - are turning out to have problems long after they've reached the market. With more than 40 percent of the U.S. population taking at least one prescription medication, the ever-growing list of medication concerns is drawing public attention and a sharp eye from consumer watchdogs. Research within the past week has raised questions about Vytorin, a popular cholesterol-lowering drug, and an analysis published in the New England Journal of Medicine suggested doctors and patients may have been misled about the effectiveness of many antidepressants.

psychiatric side effects of experimental medicines

After decades of inattention to the possible psychiatric side effects of experimental medicines, the Food and Drug Administration is now requiring drug makers to study closely whether patients become suicidal during clinical trials. The new rules represent one of the most profound changes of the past 16 years to regulations governing drug development.

Antidepressant Studies Unpublished

The makers of antidepressants like Prozac and Paxil never published the results of about a third of the drug trials that they conducted to win government approval, misleading doctors and consumers about the drugs’ true effectiveness, a new analysis has found.
In published trials, about 60 percent of people taking the drugs report significant relief from depression, compared with roughly 40 percent of those on placebo pills. But when the less positive, unpublished trials are included, the advantage shrinks: the drugs outperform placebos, but by a modest margin, concludes the new report, which appears Thursday in The New England Journal of Medicine.

WHO aims to balance drug companies, poor

GENEVA - The U.N. health chief urged countries on Monday to come up with new ways to make medicine for HIV/AIDS and other diseases more affordable in the world's poorest countries, without stifling innovation among pharmaceutical companies.
The World Health Organization's 193 member states are hoping to forge a global strategy on the highly divisive issues of drug development, patenting and pricing by the end of the week.
"People should not be denied access to lifesaving and health-promoting interventions for unfair reasons," said Dr. Margaret Chan, WHO's director-general, in opening the agency's first meeting devoted to the subject since May, when the United States walked out of a negotiating session and dissociated itself from a WHO resolution.
Under rules agreed by the World Trade Organization, countries can issue so-called "compulsory licenses" to disregard patent rights, but only after negotiating with the patent owners and paying them adequate compensation. If they declare a public health emergency, governments can skip the negotiating.
Brazil and Thailand have invoked the procedure to import cheap generic versions of American AIDS drugs, among other medicines, to treat patients who developed resistance to older anti-retrovirals and needed more expensive, second-line drugs.
The moves by Brazil and Thailand were praised by health campaigners but criticized by industry groups. The United States later placed Thailand on a copyright watch list of nations where American companies face problems protecting intellectual property rights. Countries on the list are under extra scrutiny and can face trade sanctions if alleged violations worsen.
The international aid group Oxfam says compulsory licensing almost never occurs because developing countries face pressure from rich governments acting on behalf of their drug companies. Its report last year on drug access cited WHO statistics that 74 percent of AIDS medicines are still under monopoly, and that 77 percent of Africans still lack any access to AIDS treatment.

Lawmaker Calls for Registry of Drug Firms Paying Doctors

WASHINGTON, Aug. 3 — An influential Republican senator says he will propose legislation requiring drug makers to disclose the payments they make to doctors for services like consulting, lectures and attendance at seminars.
The lawmaker, Charles E. Grassley of Iowa, the senior Republican on the Senate Finance Committee, cited as an example the case of a prominent child psychiatrist, who he said made $180,000 over just two years from the maker of an antipsychotic drug now widely prescribed for children.

A National Survey of Physician–Industry Relationships

A new national survey finds nearly all physicians (94%) have some type of relationship with the pharmaceutical industry—from receiving drug samples or food in the workplace, to being reimbursed for professional meetings, to receiving consulting fees.
The authors of "A National Survey of Physician–Industry Relationships" (New England Journal of Medicine, Apr. 26, 2007) document widespread relationships between physicians and the pharmaceutical, medical device, and other medically related industries, and also find that such relationships vary according to type of specialty, practice setting, and other factors.