The Crisis in Drug Pricing
Many living with HIV appreciate the contributions that the pharmaceutical industry (hereafter called "pharma") has had on their lives and health, at least if they have access to the drugs. In a relatively short time, it developed more than 20 anti-HIV drugs. The success of basic and clinical research funded by the National Institutes of Health (NIH) combined with the drug development expertise of pharma gave new hope and new life to people afflicted by one of the worst diseases ever known. Activists must balance this against the high prices of the drugs and harm such prices do in the battle for universal access to treatment.
Drug prices have long been a problem, now further complicated by the ballooning federal deficit. The U.S. government will spend at least $500 billion more than it collects in 2004. The budget resolution, now in debate, could contain provisions that would further damage essential domestic programs for many for years to come. State governments face their own budget crises. Consequently, many ADAP programs are reducing the lists of drugs covered and/or the number of people served. More than 1,600 people are already on ADAP waiting lists because of inadequate resources and high drug prices.
Another issue is the recent passage of a partial Medicare prescription drug benefit for the elderly and disabled, who are deeply affected by drug prices. The program helps only some people and doesn't guarantee access to drugs, yet it will cost taxpayers at least $534 billion over the next 10 years. Some estimate that a comprehensive drug benefit for senior citizens, at current prices, would cost close to two trillion dollars. Every new increase in drug prices will make things worse.
Pharma's justification for high U.S. drug prices is that they are necessary to finance research and development (R&D) into new drugs. They argue that the lower prices charged in almost all other countries (typically forced by local regulations) allow little margin for new research. Thus, U.S. taxpayers must subsidize the costs for everyone. No one wishes to force prices so low as to discourage R&D, but there's considerable dispute whether lowering prices would harm future research. It is not clear that European prices, for example, are insufficient to contribute to R&D, and there are many other ways to reduce industry spending, as described later.
A few companies have attempted to keep prices down. For example, Merck originally priced its protease inhibitor indinavir thousands of dollars lower annually than competitive drugs. Others have been less responsible citizens, setting ever higher prices for new drugs and repeatedly raising the price of older drugs for higher profits. Abbott Labs recently raised the price of its protease inhibitor ritonavir several hundred percent in a single step, setting off a storm of criticism and legal action. Most companies prefer a lower profile, quietly making 5-10% increases one or more times a year. Over time, this adds up to major increases. In contrast, we almost never hear that a drug's price has been lowered after its development costs have been recovered.
Unless this trend of escalating prices is not stopped but reversed, it will hasten the collapse of the American healthcare system. The system is already overburdened by rising hospital costs, ballooning malpractice insurance costs, and a rapidly increasing number of uninsured and underinsured people. Pharma, which as a whole is the most profitable industry in America, must understand the part it plays in this time of crisis. While people and institutions suffer greatly, it has come to look greedy and insensitive. It is failing to convince the public and policy makers that its high prices are needed to sustain R&D. Something must be done. The only question is whether it will be voluntary change or forced.
Possible solutions are routinely discussed, and some have been tried. To date, there's no national consensus on any of these and views are sharply polarized. The most commonly discussed solutions include:
Some forms of price control are already used in the U.S., like forced discounts for ADAP and Medicaid as well as negotiated prices for the Veterans Administration. In Europe, several different approaches help contain prices. European type controls (ranging from cost-effectiveness evaluations, to price comparisons with similar countries, to industry/government negotiations) offer promise, but only when there is a political consensus about their use. It's hard to get a political consensus on anything in Washington. The fact that the U.S. would be the last major industrial country to widely use such controls would bring more burdens to the negotiating table, particularly in terms of how they would affect investment in pharma -- and thus the effect on future drug development.
Although price controls are intensely opposed by the present Administration, the mere discussion of them is important and might influence the leadership of pharma. This debate must be encouraged. If industry leaders really believe that price controls would be disastrous to their business, they can easily avoid them by offering their own plan to reduce prices and begin acting more responsibly.
Drugs are cheaper in Canada because its government negotiates prices under the Canadian national healthcare plan. But if large numbers of U.S. citizens, or even whole states, take advantage of Canadian pricing, a huge problem can develop -- Canadians may soon be pitted against U.S. buyers. The vast majority of these lower priced Canadian drugs are made by the same companies that sell them in the U.S. at higher prices. Those companies are not going to start shipping greater quantities of their drugs to Canada so that they may be re-imported to the U.S. at lower prices.
Several major drug companies have announced that unless the practice stops, they will stop or greatly curtail shipments to Canada. In addition, advocacy groups in other countries are likely to protest. Already, several of Canada's advocacy groups have petitioned its government to stop sales to the U.S. through internet pharmacies. Another option for industry would simply be to increase prices to all countries, thus undermining the value of re-importation to the U.S. while also harming the interests of citizens of other countries. Such a response could undermine all the progress that has been made in securing lower drug prices for developing nations.
Industry supporters argue that re-importation is, at its core, a way to import price controls into the U.S. Well-meaning efforts to buy lower-cost drugs this way amount to the U.S. fighting its drug-pricing war on another country's soil, potentially at the expense of their citizens and healthcare systems. There's also growing pressure from the U.S. on the World Trade Organization to establish trade barriers to these practices. Like price controls, however, discussion of re-importation schemes may help stimulate public debate. Whether compromise is possible depends on the scale of re-importation.
Drugs, however, almost never get the full 20 years of protection due to the long lag time between getting a patent and when a drug comes to market. If it takes 10 years to bring a drug to market, it would only have 10 years of protection left in the marketplace. Drugs are allowed to get back an extra year of patent protection for every two years spent in the FDA approval process, up to a maximum of 5 years of patent extension. But they are limited to no more than a total of 14 years of exclusive marketing after FDA approval. There are, of course, ways that companies get around this, such as making slight changes in their products and calling them "new" drugs when the patents run out.
Some believe that patent protection may be working too well for prescription drugs, seen by pharma's extremely high prices and high profits compared to other industries. Thus, the threat of further reducing patent protection, or perhaps eliminating the 5-year extension might warrant discussion. But changing patent laws would be very difficult, as the basic patent laws apply to all inventions, not just drugs. It has taken decades to work out the mechanisms of patent protection for drugs, and there's a strong interest in keeping the rules consistent from one country to the next. Policymakers realize that shorter patents, which could hasten generic competition, would likely also result in higher, rather than lower, prices for branded drugs during their patent life.
The tough questions are: Who will do the work? Who will fund it? Who has the infrastructure and experience? How would new discovery be fostered in a public setting? Right now, there are no clear answers, other than the existing pharmaceutical industry. Neither government nor anyone outside pharma has the infrastructure for large-scale drug development and manufacturing. Government funds a great deal of basic research, but it is only minimally involved, if at all, in "drug development."
While some may cite Brazil as a recent exception with its production of anti-HIV drugs, it has at best only performed the functions of a generic drug company. It did not create, develop or test any of the drugs it now manufactures. Even if society were to move in this direction, it would take decades to create a public sector process that could compete with industry.
What remains undefined though is just how much government involvement in a drug's history is needed to make a seizure legal. A large percent of new drugs will have some form of government grant in their history, simply because the NIH funds basic research that leads to new drugs and cures. Patent applications typically list such grants, but this doesn't prove that the government owns or has rights to the patent or product. Another uncertain factor is to what degree access to the drug is being harmed by the company's actions. In the case of the ritonavir pricing action, there are also efforts to test in court whether the company's actions have harmed patients or the drug's competitors. All these matters remain undecided for now.
Still, the threat of such action -- successful or not -- will cause companies to think hard before acting in the future.
The senior managers of pharma must balance many conflicting interests: people want better therapies as quickly and as cheaply as possible; stock owners want to see high profits; institutions that invest employee pensions in drug company stocks want to see their funds grow; regulators want the highest quality data and product; scientists seek investment in their area of expertise and interest; and a lot of ordinary folks who happen to work in the company, with families, needs and lives of their own want to feel good about what they're doing. It is too easy, and unfair, to see drug companies and their executives and employees simply as greedy monsters. But they are indeed people who need to face change.
High profits cannot be allowed to come at the cost of denying people access to medicine, crippling their financial security or undermining our healthcare system. More money should not be spent on marketing than research. The "me too" drugs in their portfolios should not outweigh innovative advances against disease.
The core of the problem is that pharma has often been pushed and molded more by Wall Street than the Hippocratic Oath. The people in this industry need to get serious about the crisis of drug pricing, from the Chief Executives and Clinical Researchers to the Community Relations Managers and heads of Marketing. The system is broken and must be fixed. No one could fix it more quickly than those who run the companies.
As prices have soared, the number of new drugs and devices being submitted for FDA approval has actually declined. In recent years, the industry has consolidated as a few large companies have bought up more and more of the smaller ones. Yet these acquisitions seem to have done more to crush competition than to develop more and better products. How is the public served by this?
Pharma must rethink and restructure its business model. If they truly believe they can't sell drugs for substantially less without harming R&D, they need to ask, "What can we cut? What must we change?" At the same time, government must rethink its all too cozy relationship with the industry. A few suggestions for government and industry follow.
Change the Law That Allows Direct-to-Consumer (DTC) Advertising by Drug CompaniesBillions of dollars could be freed up over the next 5 years to permit lower drug prices, without spending a nickel less on R&D. Vast amounts of corporate cash now go into DTC advertising. This was banned until well into the 1990s, when Congress "gifted" the right to industry.
Although some surveys suggest that doctors and their patients benefit from advertising, these are simply opinion surveys. There is no evidence that people are medically served by such advertising. Continued bans on this advertising in most other developed nations don't seem to hurt anyone.
Set Limits on LobbyingPharma spends more money on lobbying Congress, the Executive Branch, political parties, and state governments than any other industry. It may also spend more on lobbying than on R&D. (Because of complex accounting practices, it's difficult to know what they spend on anything.) The need to reduce spending in this area requires no explanation.
Remove Any Bans That Prevent Government Payers, Like Medicare, From Negotiating Prices With PharmaWhile some government purchasers do negotiate drug prices, a key provision of the new Medicare prescription drug benefit is a ban on negotiating prices with manufacturers. This makes no sense in a country, and under an Administration, that claims to believe in free market forces. The ability to negotiate prices is perhaps the most fundamental tool of a free market economy. Drug prices are negotiated in some way with industry in almost every other industrialized nation.
Use the "Bully Pulpit" of the Presidency to Encourage Lower Drug PricesPharma currently spends hundreds of millions of dollars to gain the favor of the White House, and it seems to get what it pays for. The president has made it clear he would never consider price controls. So what is his solution then? Let the White House make use of its friendly relations by telling industry what's needed for the good of the people and the country in these difficult economic times. Pharma can't "take its business elsewhere" because no place else in the world is willing to pay the high prices routinely accepted here.
Let the Boards of the Major Pharmaceuticals Restructure Executive Compensation PackagesThis would reward competitive pricing strategies and better product development, rather than just short-term profits. Competitive pricing and better products are perhaps the best ways to increase sales and market share.
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