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November 15, 2007

Desperate, Drug Makers Court Doctors in Developing Countries

In the U.S. we are accustomed to seeing exceptionally well-dressed drug company reps strolling into doctors’ offices bearing trinkets: coffee cups, note pads and pens. We also know that they take doctors to expensive dinners, and host “continuing education” junkets to warm climes. Device-makers have been known to ferry doctors to strip clubs after dinner.

But in the developing world, drug makers are pulling out all of the stops. Often there is not even a pretense that the gift will help the doctor do his job. In Kashmiri, a physician confides, “representatives of pharmaceutical  companies offer cash, refrigerators, color televisions, laptops, PCs, mobile phones, ovens, phone bills, [and even to pay school] tuition [for your] children.”

In India, a doctor from Mumbai reports:  “On sale of 1,000 samples of the drug, you get a Motorola handset. On sale of 5,000 samples you get an air cooler. On sale of 10,000 samples get a motor bike.”

In Pakistan, a survey of 149 doctors, 100 medical information officers (sales representatives) and 99 medical store personnel, found that gifts may include included air conditioners, cars, cash, home appliances and domestic cattle.   Murad M. Khan, professor & chairman of the department of psychiatry at Aga Khan University, describes the latest practice: For writing 200 prescriptions of a company’s high-priced drug, a doctor is rewarded with the down payment on a brand new car.

These are just a few of the enticements documented in a November 2007 Consumers International (CI ) study, "Drugs, Doctors and Dinners: How Drug Companies Influence Health in the Developing World." (Thanks to Gary Schwitzer, at Schwitzer Health News Blog, for calling attention to this report.) A global voice for consumers, CI is an independent not-for-profit boasting over 220 member organizations in 115 countries.

CI’s eye-popping 39-page investigation reveals how, as profits level off in the West, drug makers are turning to the rest of the world: “The pharma industry sees the developing world as a trillion-dollar opportunity,” CI’s Richard Lloyd recently told the U.K. newspaper, The Independent.  But as Lloyd noted, here’s the catch:  “consumer health expenditure in these countries can ill afford to be squandered.”

In the developing world, a health care dollar that is wasted is not easily replaced.  Yet waste is rampant. According to CI, “up to half the drugs prescribed in the developing world are wrongly prescribed.” [my emphasis]

A 2005 study by the Indian National Commission on Macroeconomics and Health confirms that as drug-makers hustle their products, doctors are prescribing drugs that are “irrational or non-essential or hazardous.” Taking a close look at the country’s 25 top-selling brands of medicine, listed by drug and manufacturer, the Commission found that ten of the 25 fell into that category (see table below.)

    “Irrational, Non-Essential or Hazardous” Products

Rank            Brand               Producer      Headquarters
1                Becosules           Pfizer               USA
3                Corex                 Pfizer              USA
9                Liv-52                Himalaya         India
11              Dexorange        Franco-Indian   India/France
12              Digene              Abbott              USA
17              Combiflam        Aventis             France
20              Polybion            E. Merck           Germany
21              Glucon-D           Heinz                USA
22              Evion E.            Merck               Germany
25              Revital              Ranbaxy            India

Even worse, in the developing world, manufacturers are flogging drugs that regulators in the West have nixed.  For example, in 2005 the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) refused to recommend authorization to let Novartis market a treatment for  irritable bowel syndrome known as Zelmac (Zelnorm in the U.S.) in part because CHMP thought the drug’s benefits did not outstrip its risks.   In the U.S. the FDA approved Zelnorm, but only for women suffering from severe chronic irritable bowel syndrome.  “In its ads, Novartis Pakistan does not state that Zelnorm is recommended for women only,” CI  observes. “It is not known how many Pakistani men are suffering from the serious side effects associated with taking Zelnorm.”

Drug companies also appear to be pushing drugs that “have been recalled, or are the subject of safety scares, in developed countries,” CI continues. “Such incidents include the well reported VIOXX case, GSK’s Seroxat and Avandia106 and AstraZeneca’s Crestor.  Despite these scares, the drug companies continue to promote these products in . . . markets, where pharmaco-vigilance standards are lagging.”

The report concludes: “the poor quality of information provided to doctors in developing countries cannot be dismissed as infrequent and isolated cases, but rather can be viewed as a systemic breach of responsibility and ethical norms by market leaders.” This is not good publicity for the pharmaceutical industry. And it’s a business that could use a brighter image.

Why, then, are industry leaders playing fast and loose in the developing world?  Desperation. This is a mature industry, and earnings just aren’t growing as fast as they once did. Today, drug-makers have few potential block-busters in the pipeline; most of what comes to market is another me-too drug, no better than, and often riskier than, medications that are already available. A breakdown of more than 1,000 new drugs approved by the US Food and Drug Administration between 1989 and 2000 revealed that more than three-quarters had no therapeutic benefit over existing products  When the British Medical Journal published a study rating newly patented drugs in Canada it rated only 5 percent as “breakthrough.” Genomic research may lead to another leap forward—but not next year.  And Wall Street is not known for its patience.

Meanwhile, patents on prescription drugs are running out. By 2009, a dozen of today’s top 35 branded prescription drugs will lose patent protection, CI reports. And “expiring patents expose an estimated $157 billion worth of sales (measured in 2005 terms) to generic erosion.”

Of course, making drugs and peddling them to the public is still a lucrative venture. But investors don’t just expect profits—they demand sales and earnings growth, year after year after year. And as the table below shows, growth has leveled off in recent years, falling from 14.5 percent in 1999 to 7 percent in 2006:

                           Pharmaceutical   Industry Growth 1999 to 2006

Global sales US$BN           1999    2000   2001   2002  2003  2004   2005 2006
Total world market (US$)   334      362    387    427    498    559    601   643
%Constant US$ growth      14.5      11.7  11.8   10.6   10.4   8.0     6.8   7.0

But if sales in Europe and North America are beginning to disappoint, India’s enormous market offers hope: in 2006, pharmaceutical sales levitated by 17.5 percent, climbing to $7.3 billion. This would be fine if drug makers were providing Indians with the products they need—at prices that they, or their government, can afford. But instead the industry is bent on promoting its most expensive, high-margin wares—drugs that often aren’t necessary, and may even do harm. A Darwinian struggle for profits in the developing world has brought the pharmaceutical industry to a new low.

In the British Medical Journal, Chandra M. Gulhait of India’s Monthly Index of Medical Specialty sums up Big Pharma’s business plan: “Fiercely competing pharmaceutical companies [are depending]  on the tried and tested 3Cs: convince if possible, confuse if necessary, and corrupt if nothing else works.” 

Comments

mahfouz

is dexorange available in the netherlands?

Dan

I agree that drug companies can be sketchy at times. Zelnorm was a great example since if was found to significantly increases the risk of adverse cardiac (heart attack and stroke). Ennis & Ennis is the lawyer to consult if you have suffered from a medical side effect. Zelnorm is merely one of the drugs he is involved in. www.ennislaw.com

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