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Why the Pharmaceutical Industry’s "R&D Scare Card" Does Not Justify
High and Rapidly Increasing U.S. Drug Prices

 

 January 26, 2000

 

Introduction

Major U.S. drug companies and their trade association, the Pharmaceutical Research and Manufacturers of America (PhRMA), have launched an all-out propaganda campaign to scare policy makers and the public into believing that if anything is done to restrain high and rapidly increasing U.S. prescription drug prices, research and development (R&D) to find new treatments for serious and life-threatening diseases will suffer.

The $30+ million "Flo" advertising campaign and countless op-eds, studies, interviews and other communications by the industry and its hired-gun think tanks and consultants succeeded in stopping Congress and the President in 1999 from negotiating and passing an affordable outpatient Medicare prescription drug benefit. As the recent exposure of parts of PhRMA’s secret playbook for the first months of 2000 reveals, we can expect much more of the same this year.

PhRMA’s R&D Scare Card argument is a "Big Lie" campaign: proponents seek to convince through fear and repetition, not logic or evidence. Those seeking the truth are at a particular disadvantage because of the almost complete lack of transparency that surrounds the subject of pharmaceutical research. The only players who know what is actually spent on R&D and what proportion of those expenditures are divided between marketing research vs. research into "me-too" drugs vs. research into drugs of major therapeutic significance are the drug companies - and they do not make this information public. Instead, through PhRMA and other hired flacks, they churn out self-serving and misleading propaganda designed to protect their ability to charge whatever they determine the market will bear.

This primer brings together some known facts that rebut the drug industry’s R&D scare campaign. They lead to the following conclusions:

Brand-name prescription drug companies rely on R&D to make money: it is the source of new patents, new products, and future profits. Twice in recent history the industry has played the R&D scare card and been proven false. When the 1984 Waxman-Hatch Act was under consideration, PhRMA, although strongly in favor of the patent extension provisions of the bill, warned that the bill’s provisions easing generic competition would hurt R&D. But according to PhRMA, in the 15 years after the Act passed brand-name company R&D quadrupled. Again when Congress was considering imposing price restraints on Medicaid drug prices in 1990, the industry threatened that they would have a chilling effect on research and development. But in the five years after Congress acted, R&D expenditures increased by 75%. Common sense suggests that these firms are not going to commit business suicide by curtailing R&D.

 

PhRMA’s Figures on U.S. Pharmaceutical R&D Expenditures Are Inflated and Misleading

The Pharmaceutical Research and Manufacturers of America’s (PhRMA) web home page proudly trumpets that its member companies spent a worldwide total of $21 billion in 1998 "to develop and discover new medicines." [www.phrma.org home page] The implication is that these expenditures are to find and develop new treatments for serious and life-threatening diseases. Neither PhRMA nor individual drug companies publicly disclose exactly what is included in their claimed R&D expenditure total. However, evidence suggests that a significant amount does not reflect the cost of developing and discovering new treatments for serious and life-threatening conditions, but instead goes into "me-too" drugs and into marketing research.

A High Percentage of New Drugs Approved Are "Me-Too" Drugs

Until 1992, the Food and Drug Administration classified every new drug approved according to its significance for human health. The ranking system:

1A = Important therapeutic gain: a breakthrough drug
1B = Modest therapeutic gain: e.g., change in formulation so that the drug can be taken once instead of three or four times a day
1C = Little or no therapeutic gain:  "me-too" or "copycat" drug - for all practical purposes, duplicate of products already available
1AA = AIDS and related conditions
OD = Orphan Drug

More than Half of New Drugs Approved from 1982-1991
Were "Me-Too" Drugs

FDA Category Number Percent
1A - Important Therapeutic Gain 41 16%
1B - Modest Therapeutic Gain 80 31%
1C - Little or No Therapeutic Gain 137 53%
Total New Drugs Approved 1982-91 258 100%

Source: Donald Drake and Marian Uhlman, Making Medicine, Making Money (1993), p. 72

As seen above, more than one-half (53%) of the newly discovered drugs had "little or no therapeutic gain" compared to drugs already on the market.

The pharmaceutical industry hated this system, because it provided objective information - not drug company advertising or pitches from sales representatives - to the public and medical practitioners about the true value of a majority of their products. In response to industry pressure, the Bush Administration eliminated these rankings in 1992.

Although our ability to track the exact proportion of "me-too" drugs ceased with the demise of this ranking system, more recent evidence still confirms that a relatively small proportion of the drug industry’s claimed R&D expenditures are directed at the discovery of new treatments for serious and life-threatening illnesses:

Drug Industry’s Claimed R&D Expenditures Also Include Marketing Research

Because drug companies refuse to provide a breakdown of their claimed R&D expenditures, it is not possible to identify exactly what proportion is market research - designed to launch the advertising and doctor promotion campaigns that are the hallmark of the introduction of new drugs. However, evidence suggests that a considerable - and growing - part of what the industry calls R&D is not devoted to "finding and developing new medicines," but goes instead into marketing research:

Where’s the Risk? The Pharmaceutical Industry Consistently
Ranks Tops in Profits

PhRMA and major drug companies attempt to justify high U.S. prescription drug prices by characterizing their business as a high risk enterprise which must therefore be rewarded with concomitantly high returns. But where’s the risk? Company reports to the Securities and Exchange Commission and Fortune magazine’s annual surveys of comparative industry rankings show that:

Average of the Median Return on Revenue and Equity
Pharmaceuticals Compared to Fortune 500 All Industries, 1970s - 1990s

Decade

Median

Profit* as % of Return on Revenue
All Industries

Median

Profit* as % of Return on Revenue Pharmaceuticals

Median

Profit* as % of Return on Equity
All Industries

Median

Profit* as % of Return on Equity Pharmaceuticals

1970s

4.4%

8.9%

12.4%

16.5%

1980s

4.4%

11.2%

13.3%

20.0%

1990s

4.0%

14.7%

12.4%

26.5%

* Averaged for each decade.
Source: Computed from Schondelmeyer, Table 12.

 

Profits, not R&D, Is the Top Priority for Major U.S. Drug Companies

While PhRMA’s propaganda campaign goes to great lengths to portray R&D as the top priority for the pharmaceutical industry, company reports to their shareholders and the Securities and Exchange Commission tell a different story. Profits, not R&D, is this industry’s top priority. As the table below shows, the top ten U.S. pharmaceutical companies ranked by sales made profits [net income] a much higher priority than R&D. Only one of the ten spent more on R&D than profits in 1998. The median for the ratio of net income to R&D for the top ten was 1.5.

Leading Pharmaceutical Companies Place Profits above R&D

Company

Net Income as a Percent of Net Sales

R&D as a Percent of Net Sales

Ratio of Net Income to R&D

Bristol-Myers Squibb

17.2%

8.5%

2.0

Abbott

18.7%

9.8%

1.9

Merck

19.5%

10.6%

1.8

Schering-Plough

21.7%

12.5%

1.7

Am. Home Products

18.4%

12.2%

1.5

Pfizer*

24.7%

16.8%

1.5

Warner-Lambert

12.3%

8.6%

1.4

Johnson & Johnson47

13.0%

10.3%

1.3

Eli Lilly

22.7%

18.8%

1.2

Pharmacia&Upjohn

10.2%

17.7%

.6

*Includes Alliance revenue.
Source: Fortune Magazine's top ten pharmaceutical companies ranked by sales, in this chart in declining order by ratio of net income to R&D. Company figures from 1998 Annual Reports, Table of Consolidated Statement of Earnings.

The bottom line is clear: drug companies do not have to curtail R&D to absorb the price restraints necessary to make a Medicare benefit affordable and still remain the richest industry in the U.S.

 

Merrill Lynch Finds the Prescription Drug Fairness for Seniors Act
Would Cut Drug Company Revenues by Only 3.3%

In a June 23, 1999 report, Merrill Lynch debunked the notion that a Medicare prescription drug benefit would seriously damage the pharmaceutical industry’s profitability [A Medicare Drug Benefit: May Not Be So Bad]. Merrill Lynch’s analysis concludes that the toughest proposal on the table in Washington, the Prescription Drug Fairness for Seniors Act (H.R. 664/S. 731), which provides a 40% discount on drug costs for all 39 million Medicare beneficiaries, would cut just 3.3% from total pharmaceutical industry revenues because volume increases would offset much of the lost revenue due to the lower prices. According to Merrill Lynch:

The following table illustrates the potential impact of a 3.3% reduction in sales on the top ten drug companies [the actual impact of the Prescription Drug Fairness for Seniors Act on individual companies would vary by factors such as the percentage of total sales earned in the U.S. and the proportion of products used by Medicare beneficiaries].

Change in 1998 Sales and Profits of Top 10 Drug Companies
Under the Prescription Drug Fairness for Seniors Act (H.R. 664/ S.731)

1998 Sales

1998 Profits

($ millions)

Actual

H.R. 664/ S.731

Actual

H.R. 664/ S.731

Merck

$26,898

$26,002

$5,248

$5,073

Johnson & Johnson

23,657

22,869

3,059

2,957

Bristol-Myers Squibb

18,284

17,675

3,636

3,515

Pfizer

13,544

13,093

3,351

3,239

American Home Products

13,463

13,014

2,474

2,392

Abbott

12,478

12,062

2,333

2,256

Warner-Lambert

10,214

9,874

1,254

1,212

Eli Lilly

9,237

8,929

2,098

2,028

Schering-Plough

8,077

7,808

1,756

1,698

Pharmacia & Upjohn

6,758

6,533

691

668

Source: 1998 Sales and Profits from 1998 Annual Reports.

 

Promotion and Advertising, Not R&D, Are the Drug Companies’ Fastest Growing Expenditures

Since Senator Kefauver’s pathbreaking hearings into the business practices of U.S. pharmaceutical companies in the late 1950s, the industry’s investment in marketing to gain and maintain market share has been well documented. Public Citizen’s Health Research Group has exposed the negative impact on consumer and patient health which the industry’s slick and all-but-unregulated marketing practices produce [see www.citizen.org/hrg/publications/drugs then scroll down to "promotion" for a list of publications]. Since the FDA relaxed standards for Direct-to-Consumer (DTC) TV ads in 1997, drug advertising - and its negative consequences - have escalated rapidly.

Promotion and advertising is also a major driver of high drug costs and a major contributor to the diversion of R&D spending into marketing research. The lack of transparency surrounding U.S. pharmaceutical industry R&D expenditures precludes identification of exactly how much of PhRMA’s claimed R&D spending goes into marketing research. But experts in the field estimate it is a considerable share of what is labeled "R&D."

 

U.S. Taxpayers Play an Important Role in Funding Pharmaceutical R&D

Unacknowledged by PhRMA’s R&D propaganda campaign is the significant role of U.S. tax dollars in funding biomedical, including pharmaceutical, research. Taxpayer-funded R&D is in addition to the hefty tax breaks enjoyed by the U.S. drug industry.

Effective Tax Rate for U.S. Drug Companies Much Lower than Other Industries

Many Important Pharmaceutical Breakthroughs Are Taxpayer-Funded

Unfortunately, the federal government does not provide comprehensive data on the amount of taxpayer funded pharmaceutical research, its role in discovering and developing drugs that are brought to market by private firms, or the relative return it produces for company shareholders vs. U.S. consumers and taxpayers. A variety of sources provide evidence that taxpayer dollars support an important share of the research that has produced major breakthroughs.

Gift of Public Funds

Much of this taxpayer-funded research is practically given away to private industry. The Boston Globe reported that NIH spent at least $1 billion on drug and vaccine development in fiscal 1996, but took in only $27 million in royalties from companies. [Dembner, Alice, "Public Handouts Enrich Drug Makers, Scientists," Boston Globe, April 5, 1998]

As the following table shows, U.S. consumers and healthcare payors are also big losers, as drug companies market essential drugs developed with taxpayer dollars at exorbitant prices and pocket the profits.

Examples of Industry Profiteering from Drugs Developed with Government Funds

Drug/Used For

Government Role in Development

Drug Company Charges/Profits

Taxol - Breast/other cancers NIH spent 15 years and $32 million developing Taxol. Bristol-Myers Squibb (BMS) granted exclusive marketing rights; charges cancer patients $10,000 - $20,000 annually - more than 20 times what the drug costs to produce - earning BMS over $1 million every day.
Levamisole - colon cancer NIH supported study of Levamisole [a drug used to treat worms in farm animals] for use in humans for 12 years leading to Dr. Charles Moertel’s discovery of its effectiveness against colon cancer. Johnson & Johnson raised the price from .06 per pill to $6.00 for use by humans. Dr. Moertel said the drug’s development was "paid for just about in full by the American taxpayer. We gave it to them on a silver platter."
Proleukin - kidney cancer NIH conducted or funded nearly $46 million in clinical trials to win FDA approval for Proleukin. Chiron Corporation charges kidney cancer patients up to $20,000 annually for Proleukin.
AZT - HIV/AIDS NIH spent years and tens of millions of dollars developing AZT, the first drug approved to treat AIDS. Glaxo-Wellcome was given monopoly rights over the drug. It first charged $10,000 annually (now about $3,000); the companies stock value increased ten-fold after AZT went on the market.

Source: "Examples of Drugs Developed with Government Funds," Project on Government Oversight Fact Sheet, February 1, 1999.

 

PhRMA’s Claim that High U.S. Drug Prices Lead U.S. Firms
Perform a Disproportionate Share of R&D is False

The pharmaceutical industry is a global industry dominated by large multinational companies. Since the 1980s, U.S. pharmaceutical companies have merged with and or acquired significant stakes in European firms, and vice versa. All drug companies, regardless of where their national headquarters is located, charge higher prices in the U.S. market. It is absurd to posit, as PhRMA’s propaganda does, a national link between U.S. drug prices and U.S. research and development spending.

Data from the U.S. International Trade Commission (USITC) Research Study Review of Global Competitiveness in the Pharmaceutical Industry [April 1999] shows the absurdity of PhRMA’s claims. According to the ITC, in 1996, the U.S. accounted for 33% of the total world market for prescription drugs; Western Europe, 29%; and Japan, 18%. Yet even when PhRMA’s inflated figures for U.S. drug company R&D are used, R&D spending by firms in Western Europe exceeded that of U.S. drug companies.

1996 Pharmaceutical R&D Spending in U.S., Western Europe, and Japan

Country or Region

Pharmaceutical R&D
[US $]

Percent of Total for Three Regions

United States

$13.6 billion

39.9%

Western Europe

$14.4 billion

42.2%

Japan

$ 6.1 billion

17.9%

Total for Three Regions

$34.1 billion

100.0%

Source: USITC Study, pages 3-1, 3-7, 3-18 and 3-27

Nor does the U.S. outshine the world in breakthrough research, as measured by the number of new chemical entities (NCEs) developed:

New NCEs Developed by Major Country or Group, 1990 - 1994

Country or Region

Total NCEs Developed

Percent of Total

United States

84

32.4%

Western Europe

94

36.3%

Japan

77

29.7%

All Other Countries

4

1.6%

World Total

259

100.0%

Source: USITC Study, page 2-3

The above tables show that the countries of Western Europe, where prescription drug prices are 25% to 50% less than in the U.S. due to government negotiations with drug companies for fair pharmaceutical prices, are also home to significant pharmaceutical research. It simply does not follow, as PhRMA’s propaganda campaign would have it, that price controls stifle R&D.

For more information contact Maura Kealey at (202) 454-5116 or mkealey@citizen.org


Statement of Dr. Sidney Wolfe on Lowering Drug Costs for Elderly

Decription of PhRMA's Campaign to Undermine Prescription Drug Benefit

High and Rapidly Increasing Prescription Drug Expenditures Threaten Any Medicare Drug Benefit

Supporters and Opponents of the Prescription Drug Fairness for Seniors Act


How the Prescription Drug Industry "Buys" Special Influence in Washington

Link to Full Text and Status of H.R. 664/S.731

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