Townhall.com, Where Your Opinion Counts
Talk Radio:   Bill Bennett   Mike Gallagher   Dennis Prager   Michael Medved   Hugh Hewitt   
BREAKING NEWS  LeftArrow - Townhall.com : Conservative, Political, Republican   RightArrow - Townhall.com : Conservative, Political, Republican  
Columns, funnies & more in your inbox!
  • Check the boxes and send us your email address to receveive your free newsletter
  • Your daily must-read of conservative columns, cartoons and news. Coulter, Sowell, Krauthammer and more.
  • Townhall.com’s weekly inside scoop on what’s happening behind the scenes in the world of politics. When news breaks, we report.
  • Signup to receive the latest daily Townhall cartoons
Saturday, February 16, 2008
Carl Horowitz :: Townhall.com Columnist
Breaking Our Patents Abroad: How Not to Promote Affordable Drugs
by Carl Horowitz
Vote on It:
Average Vote:
[+] Text [-]
 
Poll
Was the Copenhagen Global Warming Summit Walk-Out a Win for the U.S.?


"To serve God's law, one must break man's law."

There's nothing new about this principle. Men throughout the ages have fought, killed and died for it. And latter-day political progressives are hardly exempt from its pull. Heavily animated by religious conviction, various Left-leaning activist organizations have come to believe that fighting poverty and disease in developing nations requires taking extralegal emergency steps. One of those steps is presenting commercial makers of life-saving drugs, especially for HIV/AIDS, with an ultimatum: Lower your prices or watch your patents become meaningless.

In this country, such a practice would be illegal. But other countries don't have to play by our rules. And that's the way these activists like it.

The Interfaith Center on Corporate Responsibility (ICCR), a New York-based nonprofit umbrella group of 275 investor organizations controlling a combined $110 billion in assets, is a prime organizer behind a worldwide movement to redefine corporate governance. At the 16th Global AIDS Conference in Toronto in August 2006, the ICCR and various affiliates distributed a new study, "Benchmarking AIDS: Evaluating Pharmaceutical Company Responses to Public Health Crisis in Emerging Markets." The report evaluated the record of 15 global drug manufacturers according to putative industry best practices, one of which is "increased licensing and technology transfer to generic drug companies." The authors praised five companies -- Abbott Laboratories (U.S.), Gilead Sciences (U.S.), GlaxoSmithKline (U.K.), Roche (Switzerland) and Novartis (Switzerland) -- for making progress on several fronts following "consultation" with shareholders, communities and non-governmental organizations. "(T)hese actions begin to bring industry practice in line with the needs of long-term investors and public health," said Cathy Rowan, corporate responsibility consultant to the Maryknoll Sisters and co-chair of ICCR's Access to Health Care Working Group.

These religious progressives, adept at playing hardball with top management, profess good intentions. But good intentions, whether or not grounded in Christian theology, don't necessarily make for sound economics. And in this case, they mask a deep animus toward profit maximization and a key means of its protection: the patent.

A patent, like a copyright, is a government grant of monopoly for a certain period of time. It secures for its holder an exclusive right to enjoy revenues from an original discovery. Though the U.S. Constitution (Article I, Section 8, Clause 8) authorizes the federal government's awarding of patents, a number of free-market economists find this anathema. Stephan Kinsella, Timothy Lee and other libertarian critics argue that requiring a patent for drugs, software or other products creates barriers to market entry among potentially more efficient competitors. This in turn raises consumer prices.

On the surface, it's a valid objection. The problem is that it exists in a legal and political vacuum. Without patent protection, especially in today's lawsuit-prone environment, few individuals and firms would have the incentive to create economically viable products. This is especially true in the highly competitive pharmaceutical industry, with its exorbitant and time-consuming front-end investment requirements and constant Food and Drug Administration oversight.

It takes on average around a dozen years, not to mention hundreds of millions of dollars worth of research, testing and marketing, to commercially launch an innovative drug. It's unlikely, for example, that the anti-blood clotting agents Persantin and Plavix would have reached pharmacy shelves had their respective manufacturers, Boehringer Ingelheim and Bristol-Myers Squibb, anticipated widespread competition from unauthorized generic (i.e., non-branded) copies. Patents uphold property rights. A drug company shouldn't be obligated to share with competitors the rewards of its discoveries any more than a homeowner should be obligated to share his dwelling with squatters.

Once awarded, a patent is no guarantee of profit during its typically 20-year life, which starts at the date of filing rather than of commercial availability. And revenues may decline, as Merck found out after its patent for cholesterol-reducer Zocor expired on June 30, 2006. Pharmaceutical firms have begun to establish generic subsidiaries -- e.g., Greenstone (Pfizer) and Sandoz (Novartis) -- precisely to avoid this outcome.

But the libertarians are right about this much: The power to grant a patent is by definition the power to deny, withdraw or undermine it. Possessed of this power, national governments exercise veto power over a firm's ability to set prices. This has major implications for American enterprise, which happens to be responsible for about 80 percent of the world's key drug and biotechnology patents. If a foreign government decides to undercut prices for U.S.-patented brand-name drugs by allowing or mandating the sale of generic versions, there is little a given company can do about it.

The recent browbeating by Brazil of Abbott Laboratories is instructive. In July 2005, that country's Ministry of Health announced a six-year agreement with Abbott in which the Chicago-area company would lower the price of its HIV/AIDS retrovirus drug Kaletra. The pact also included a technology-transfer procedure to enable the government-run Farmanguinhos Laboratories to begin producing the drug in 2009 and a provision to provide Brazilian patients greater access to Meltrex, a heat-stable form of Kaletra. The Brazilian government had declared Kaletra a drug "of national interest," and had given Abbott a 10-day ultimatum to charge a lower price or watch its profits evaporate in the face of a compulsory generic license. Initially, Abbott termed the ultimatum illegal -- which it certainly was by U.S. standards -- and warned that developing unproven, alternative medication posed "significant consequences for patients." Yet soon after, the company announced it would be open to an "agreeable solution."

Brazil, if nothing else, is an equal-opportunity abuser of rule of law. In May 2006, its government announced an "agreement" with the San Francisco-based Gilead Sciences to reduce its price of the anti-HIV retrovirus drug Viread by about 50 percent. A year later, it issued a license to produce a generic version of Merck's anti-HIV drug Efavirenz after giving the firm a week to "negotiate" a lower price.

The South African government has been of a like mind. About a decade ago, it passed a law to override existing patents in order to "determine that the rights with regard to any medicine under a patent granted in this Republic shall not extend to acts in respect of such medicine." The new law also allowed the government to license domestic companies to produce generic drugs at far lower prices, following payment of a fee to affected companies. Several dozen pharmaceutical firms doing business in that country challenged the law in court, but sustained so much public-relations damage that they dropped the suit.

Undoing the problem is easier said than done. Legalized patent infringement is woven into the World Trade Organization-administered Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) of 1994 and its more onerous successor, the Doha Declaration of 2001. The latter document explicitly authorizes governments, under cover of national emergency, to issue compulsory licenses without securing the permission of patent holders, so as "to promote access to medicines for all." Apparently, "free trade" doesn't refer to the freedom of U.S. pharmaceutical corporations to operate profitably in Third World countries.

Not surprisingly, the United Nations, hardly a reliable defender of American sovereignty, also has pulled this stunt. In the spring of 2000, following weeks of discussions with U.N. officials, several U.S. companies agreed to sell their products at prices well below even already-discounted levels. "It's the first time the companies are collectively willing to discuss a truly significant decline in prices," said Peter Piot, director of the U.N.'s AIDS program. "It is something many of us have long hoped for."

The Interfaith Center on Corporate Responsibility applauds such strong-arm practices. In November 2006, the center released an update of its "Benchmarking AIDS" study, lamenting the lack of progress by drug companies in providing "access" to essential medicines. The report did find room to congratulate the Thai government for issuing compulsory licenses for producing generic Kaletra. Yet such actions have consequences. Early in 2007, Abbott Laboratories pulled Kaletra and six other drugs out of Thailand. True to form, Christian Brothers Investment Services, an ICCR affiliate, condemned Abbott's decision rather than the action precipitating it. The ICCR, the Access to Medicines Project, Doctors without Borders, and other defenders of Third World regimes want patent protection to take a back seat to social justice.

In our own country, a drug company's main worry may be revocation. And it's already happened. On January 23 of this year, the U.S. Patent & Trademark Office revoked four key patents held by Gilead Sciences on its HIV/AIDS retrovirus drug, tenofovir disoproxil fumarate (TDF). The left-leaning Public Patent Foundation had challenged the validity of the patents, claiming that TDF's chemical properties had been known before Gilead had filed its applications.

One can't lose sight of the fact that millions of lives are at stake. But legalized extortion is a bad long-run strategy, as it harms the most vulnerable of people in nations with widespread poverty. University of Chicago legal scholar Richard Epstein explains:

Decisions like those in Brazil and Thailand cripple incentives to invest in new drugs, particularly for AIDS, for which sick people worldwide will pay the price tomorrow. What drug company will invest in new and useful products when the ensuing harsh policy will damage its global brand? Better to stand aside and let someone else take the heat. But who will step forward?

Patent infringement to some extent is an inevitable by-product of global economic integration. But its legalization, in the name of high moral principle, is nothing short of alarming. It's another example of what Czech President Vaclav Klaus calls the "denationalization of nation-states." Our nation's drug companies surely are paying the bills. One is less certain if God is collecting.

Share:
Vote on It:
Average Vote:
 
About The Author

Carl F. Horowitz is director of the Organized Labor Accountability Project of the National Legal and Policy Center, a Townhall.com Gold Partner organization dedicated to promoting ethics in American public life.
 
TOWNHALL DAILY: Be the first to read Carl Horowitz' column. Sign up today and receive Townhall.com daily lineup delivered each morning to your inbox.

Patent protection is important...
--
...but yet another method may be undertaken by the U.S. government to reduce the regulatory burden (incredibly costly in terms of time, money, and human lives) imposed upon the creators and marketers of innovative pharmaceuticals.

Early on, the FDA had served as a guardian against unsafe medications, its role greatly expanded in the wake of the 1937 incident in which Massengill marketed a preparation of sulfanilamide using diethylene glycol as an excipient as Elixir Sulfanilamide. Several deaths were caused, and subsequent legislation mandated good, strong proof-of-safety requirements.

One of the adverse consequences of the Congress' regulatory frenzy of the '50s and '60s (resulting in the damagingly burdensome increase in the stringencies of FDA regulation in 1963) was the insistance that before prescription drugs could be marketed in these United States the applicant companies had to prove to the FDA's satisfaction that their products were not only safe but *EFFECTIVE* in the indications for which marketing permission was being sought.


The average schmuck has no idea of what this does to prolong (and increase the cost of) the process whereby a new prescription drug is brought to market.

See http://www.fdareview.org/harm.shtml for more

From that article:

"Even if FDA regulations have not improved safety, they might be redeemed if they have reduced the proportion of inefficacious drugs on the market. Using a variety of tests, however, Peltzman (1973) found little evidence to suggest a decline in the proportion of inefficacious drugs reaching the market since 1962. Thus, he concluded, '(the) penalties imposed by the marketplace on sellers of ineffective drugs prior to 1962 seem to have been enough of a deterrent to have left little room for improvement by a regulatory agency.'"

We need the proof-of-efficacy requirement expunged.

--


Development cycle
My father could comment more accurately on this, but he was worked for a company that helps the drugs companies test their drugs (his company does a lot of the statistical analysis), and he told me once that out of that 20 yrs, most drug companies are lucky to get 6 yrs shelf life before the patent expires, the other 14 is spent in R&D.

Free Trade vs. Fair Trade

China Trade: Patents, Poisons, and Prescription Drugs

WATCH VIDEO

http://controlcongress.com/uncategorized/china-trade-patent s-poisons-and-prescription-drugs

Quit Complaining!
"We" have our stuff made in China. How do you think the Chinks acquired the ability "over night" to do this? We exported this in the name of free trade, thanks to the theology preached by the Council on Foreign Relations, Bilderbergs, and Trilateral Commission - and followers. A few followers and members: Clinton, Bushes, Newt, George Will, Michael Barone, John McCain. Open borders, free trade, trade with anyone irrespective of the outcome.

PATENT RIGHTS AND PHARMACEUTICALS
The existence of patent rights acknowledges the money and time required to develop pharmaceuticals and gives the patent holder(s) the ability to recoup the costs and then some.

Americans don't learn about economics in school. Too many people, because of their education, see the profit motive as "greed". Most Americans, unfortunately, appear to want to take pharmaceuticals for every little ache and pain that comes along.

And then there's the tale of the "Modern Little Red Hen". Unlike her famous forbearer, she was ordered by Government to share the profits with the idle. She never again baked bread.

Some of the regulations of the pharmaceutical industry came along after the Thalidomide disaster in the early 1960s. This drug was in widespread use in England and Germany. Many women who took Thalidomide during pregnancy bore children with serious birth defects. Thalidomide was never sold in the USA because of Dr. Frances Kelsey, an FDA medical officer, who reportedly read reports of nerve inflammation in people who took the drug long term. Dr. Kelsey wondered what the drug would do to pregnant women. Ultimately, she was regarded by many Americans as a heroine who prevented a major disaster.

How many potentially great pharmaceuticals have been kept off the market because of the Kefauver Amendment that was passed after Thalidomide?



PATENT RIGHTS AND PHARMACEUTICALS
The existence of patent rights acknowledges the money and time required to develop pharmaceuticals and gives the patent holder(s) the ability to recoup the costs and then some.

Americans don't learn about economics in school. Too many people, because of their education, see the profit motive as "greed". Most Americans, unfortunately, appear to want to take pharmaceuticals for every little ache and pain that comes along.

And then there's the tale of the "Modern Little Red Hen". Unlike her famous forbearer, she was ordered by Government to share the profits with the idle. She never again baked bread.

Some of the regulations of the pharmaceutical industry came along after the Thalidomide disaster in the early 1960s. This drug was in widespread use in England and Germany. Many women who took Thalidomide during pregnancy bore children with serious birth defects. Thalidomide was never sold in the USA because of Dr. Frances Kelsey, an FDA medical officer, who reportedly read reports of nerve inflammation in people who took the drug long term. Dr. Kelsey wondered what the drug would do to pregnant women. Ultimately, she was regarded by many Americans as a heroine who prevented a major disaster.

How many potentially great pharmaceuticals have been kept off the market because of the Kefauver Amendment that was passed after Thalidomide?



The Chickens Have Roosted
Beginning with Reagan in January 1981, Republicans have made a concerted effort to free US business from the inconvenience of government regulation. Let business police itself, said they, and free market principles will guarantee ethical performance.

Meanwhile China, as her Capitalist economy took off like a rocket, saw no reason to interfere with business by imposing silly old things like inspection and regulatory law. And if China wanted an example to follow in this, she had us.

Now chickens have come home to roost: through globalism we are buying drugs and drug ingredients from China, China is not inspecting or regulating, and we have gutted our own regulatory mechanism so we aren't equipped to pick up the slack. It appears that we are screwed. Only fair, I think.

SJ Doc
Jesus Christ, do you really think that efficacy should not be a standard in drug marketing? Think of the possibilities! Tell you what: I will cook up a mixture of cooking sherry, shampoo, and chocolate pudding in my kitchen and we will claim it cures...everything. You can bottle it and I will advertise it online, and we will split the money.

To SJDoc: Nuremburg Code
Hello SJDoc: Here is a message for you from my husband, PharmDoc. He says that after World War II the Nuremburg Code was activated in the revision of FDA standards. How did this work? The Nazis used to conduct loose medical "experiments" on prisoners just to see what would happen. "Efficacy" came into the equation in the following way: first, in screening programs, chemicals are tested on animals for a specific biological activity. After determing that you're interested in certain substances, you test for safety (dose vs toxicity, route of administration, issues of metabolism, action immediate or delayed, etc). Only then, with safety and activity established, drugs showing promise of efficacy are tested for their apparent property of addressing a specific clinical condition (the drug is given to volunteer normal human subjects) to determine a tolerated dose-range and side effects. Finally, you go into the FIRST studies giving the drug investigationally to informed and consenting human patients suffering from the target condition.

In other words, you can't just be prescribing Drug X to a patient unless you have science-based evidence not only that it is safe, but that it works. Otherwise you are relying on the placebo effect and using the whole show just to make money, and that is a violation of ethics. (I myself am not a scientist so I hope I have been accurate in wording this---PharmDoc is eating his breakfast.)

Do-gooders doing wrong
Wow, what great intentions. See a problem, declare a "fix" by stealing from others. Even the do-gooders must see they are stealing, but must rationalize "they can afford it" like a democrat on taxes. Thomas Sowell, in his book "Conflict of Visions", points out this liberal fallecy expertly as a lack of ability to see everything is a trade off: that every "fix" will "break" something else.

ICCR wants to take pharmaceutical profits, Hillary wants to take oil profits, all for "good intentions". But profits don't belong to companies, they belong to shareholders (people). So now the 529 college fund Billy's parents put aside can no longer pay for his education, our 401K's can no longer fund our retirement, people, seeing more downside than up, stop investing their money in stocks.

It's not a virtue to steal, even as a means to a virtuous end. It's still sin, as are the activities that have made HIV the problem it is.

The pharm compaies...
along with....say.... Wal-Mart, Microsoft, and big-oil should stage an Atlas Shrugged style strike, and demand free enterprise.

Of course, they probably wouldn't demand free-enterprise, but a different set of regs that protect them from competition.

Agree with sddoc & more

The pharm or harm companies have been screwing the public for years. They are totally in bed with the FDA which does relatively little to insure public health but rather to increase cost and then we'll see what happens.

Many "drugs" have been pulled forcefully when it became wide spread knowledge that they create more problems than they apparently fix.

Most true cures are found in nature. The "drug" companies then search to high heaven for a look alike and maybe efficacious substitute because they can't patent nature. If they are unable to duplicate in some way or fashion, they then put what they found in nature in a file drawer, and hope the public never finds out what they are covering up.

I have little sympathy for these monster Pharms who disrespect the public they supposedly serve. Understandable you say.??. Their motive is profit you say.??.

Sure it is. That and that only. Are you a woman who takes estrogen or your wife o9r mother does. Ask the gFDA why they have taken the natural plant based estrogen off the market and only allow "mare" (horse) urine recovery estrogen to be sold. Does your wife look like a horse.??. NO, and she's not even close to the same hormone. Breast cancer, ovaries, other female parts anyone.

The FDA is a setup for heavy bribing of the Pharms, and is no friend to the public. Of course the Pharms get their revenge by marketing useless or dangerous drugs and getting the federal government to pay for much of it.

Forewarned is fore armed.


Pardon the typos sjdoc

I get a little emotional about this subject.........

There are several cures for AIDS...

......floating around as well as numerous cures for cancer. You will never hear about them under the guidance of big PHARMA & the FDA. Wuy they would lose making millions on nearly fraudulent drugs and medical practices.

These people (sic) do not want and never will find a cure for any serious issue. Why you ask.

Profit in the multi-billions of dollars a year. They lie to you on television and the newspapers and magazines. The press is scared to death to expose them and any honest doctors are prosecuted for "alleged " crimes. Who pays a major share of advertising in the mentioned print and video sources.??. The monster Pharm companies are their biggest contributors.

I asy more power to the christian crusaders, and many more like them.


How do you know?
Horowitz: "Without patent protection, especially in today's lawsuit-prone environment, few individuals and firms would have the incentive to create economically viable products."

How do you know? See, e.g., my Revisiting Some Problems With Patents (http://blog.mises.org/archives/006930.asp); Barnett, http://papers.ssrn.com/sol3/papers.cfm?abstract_id=786545, Cultivating the Genetic Commons, (http://papers.ssrn.com/sol3/papers.cfm?abstract_id=786545) (“There is little determinative empirical evidence to settle theoretical speculation over the optimal scope and duration of patent protection.”); Merges, “On the Complex Economics of Patent Scope,” (http://cyber.law.harvard.edu/IPCoop/90merg2.html) (noting the social costs of greater duration and breadth in the form of retarded subsequent improvement)); Bell, Prediction Markets for Promoting the Progress of Science and the Useful Arts, (http://papers.ssrn.com/sol3/papers.cfm?abstract_id=925989) (“[patents and copyrights] for the most part stimulate only superficial research in, and development of, the sciences and useful arts; copyrights and patents largely fail to inspire fundamental progress. … Patents and copyrights promote the progress of the sciences and useful arts only imperfectly. ... statutory inventions do relatively little to promote fundamental research and development ….”);

How do you know? (2)
A few more: Cotter, “Introduction to IP Symposium,” ("[E]mpirical studies fail to provide a firm answer to the question of how much of an incentive [to invent] is necessary or, more generally, how the benefits of patent protection compare to the costs."); Lemley, Rational Ignorance at the Patent Office, (http://papers.ssrn.com/sol3/papers.cfm?abstract_id=261400) (“The patent system intentionally restricts competition in certain technologies to encourage innovation. Doing so imposes a social cost, though the judgment of the patent system is that this cost is outweighed by the benefit to innovation. … There is a great deal of literature attempting to assess whether that judgment is accurate or not, usually without success. George Priest complained years ago that there was virtually no useful economic evidence addressing the impact of intellectual property. … Fritz Machlup told Congress that economists had essentially no useful conclusions to draw on the nature of the patent system.”); Turner, “The Nonmanufacturing Patent Owner: Toward a Theory of Efficient Infringement,” (dubious about the efficacy of the patent system as a means of inducing invention); Hayek, The Fatal Conceit 36 (“I doubt whether there exists a single great work of literature which we would not possess had the author been unable to obtain an exclusive copyright for it... recurrent re-examinations of the problem have not demonstrated that the obtainability of patents of invention actually enhances the flow of new technical knowledge rather than leading to wasteful concentration of research on problems whose solution in the near future can be foreseen ...”).

How do you know? (2)
Cotter, “Introduction to IP Symposium,” ("[E]mpirical studies fail to provide a firm answer to the question of how much of an incentive [to invent] is necessary or, more generally, how the benefits of patent protection compare to the costs."); Lemley, Rational Ignorance at the Patent Office, (http://papers.ssrn.com/sol3/papers.cfm?abstract_id=261400) (“The patent system intentionally restricts competition in certain technologies to encourage innovation. Doing so imposes a social cost, though the judgment of the patent system is that this cost is outweighed by the benefit to innovation. … There is a great deal of literature attempting to assess whether that judgment is accurate or not, usually without success. George Priest complained years ago that there was virtually no useful economic evidence addressing the impact of intellectual property. … Fritz Machlup told Congress that economists had essentially no useful conclusions to draw on the nature of the patent system.”); Turner, “The Nonmanufacturing Patent Owner: Toward a Theory of Efficient Infringement,” (dubious about the efficacy of the patent system as a means of inducing invention); Hayek, The Fatal Conceit 36 (“I doubt whether there exists a single great work of literature which we would not possess had the author been unable to obtain an exclusive copyright for it... recurrent re-examinations of the problem have not demonstrated that the obtainability of patents of invention actually enhances the flow of new technical knowledge rather than leading to wasteful concentration of research on problems whose solution in the near future can be foreseen ...”).

More...
Cotter, “Introduction to IP Symposium,” ("[E]mpirical studies fail to provide a firm answer to the question of how much of an incentive [to invent] is necessary or, more generally, how the benefits of patent protection compare to the costs."); Lemley, Rational Ignorance at the Patent Office, (http://papers.ssrn.com/sol3/papers.cfm?abstract_id=261400) (“The patent system intentionally restricts competition in certain technologies to encourage innovation. Doing so imposes a social cost, though the judgment of the patent system is that this cost is outweighed by the benefit to innovation. … There is a great deal of literature attempting to assess whether that judgment is accurate or not, usually without success. George Priest complained years ago that there was virtually no useful economic evidence addressing the impact of intellectual property. … Fritz Machlup told Congress that economists had essentially no useful conclusions to draw on the nature of the patent system.”); Turner, “The Nonmanufacturing Patent Owner: Toward a Theory of Efficient Infringement,” (dubious about the efficacy of the patent system as a means of inducing invention); Hayek, The Fatal Conceit 36 (“I doubt whether there exists a single great work of literature which we would not possess had the author been unable to obtain an exclusive copyright for it... recurrent re-examinations of the problem have not demonstrated that the obtainability of patents of invention actually enhances the flow of new technical knowledge rather than leading to wasteful concentration of research on problems whose solution in the near future can be foreseen ...”).

When did the "health care" debate become
a debate about drugs?

In our society in general, people are over-medicated. Old people take handfulls of pills daily that turn them into walking zombies--barely walking, almost mummies.

Young and healthy movie stars die of LEGAL, PRESCRIBED medications.

Middle-aged people can't live without anti-depressants, heart medications that cause hypertension, hypertension medications that cause heart problems, diabetes medications that cause weight gain. Pretty soon they are also taking handfulls of meds, to deal with the side effects of the original meds.

Many of these ailments can be treated by diet and exercise, sufficient sleep, fresh air and sunshine, and perhaps a good quality vitamin/mineral suppliment.

I have a policy of not taking medication, and I resent that my insurance kept going up and up through the ceiling to pay for those who don't have the same policy.

I don't judge those people: let them go wild for all I care, but don't make me pay for it.

This may be controversial, but I also resent paying for meds for AIDS patients. For the last 20+ years we have known what causes HIV/AIDS, and yet people still behave like rutting animals and contract this easily preventable disease. Nowdays, there are condom machines in every men's room, and even in some ladies rooms: often they are free of charge. There are condom commercials on TV, almost as annoying as the ever-present feminine hygene ads. All it really takes is some self control. Really, that is all that is needed, and I resent paying for those who flaunt all good advice and commonsense, and then come whining to me to pay for their meds once reality bops them on the head.

Forcing People to have Health Insurance
I recently stopped paying for health insurance because I am sick and tired of my premiums going up every year even though my doctor visits have not changed: once a year for a checkup, no meds.

Medical Insurance has turned into a kind of socialism: those of us who are healthy are expected to foot the bill for those who are not.

Originally, medical insurance, and all other kinds of insurance were a kind of wager, betting on the likelyhood of one's sickness.

I happen to be between jobs, and am healthy, yet I am expected to finance the medical excesses of people who are much better off. I resent this, and decided to bet on myself that I will stay well. Much better than shelling out thousands and thousands over the years that I will never recoup.

Why Stop At Drugs?
People need lots of other things to live, why stop at drugs? Food, clothing and somewhere to live are more important for more people than medicine. If a morale imperative exists for government to appropriate that which belongs to others in the name of compassion then why not take it all? Can one of you business hating bleaders explain why government shouldn't take it all or do you agree with the sentiment?

screwing the American middle class
Horowitz has missed the major implication of this. If drugs are sold generically or at discount to foreign countries, the people who actually have to pay for the development of these drugs is none other than the American middle class. We are the designated donors for world goodness. We get no discounts and no special deals. Therefore, we are the true donors, and not the drug companies or international lawmakers who mandate special treatment of everyone else in the world.

Getting rid of FDA efficacy standards...
--
...is appropriate or a number of reasons, PharmDoc and darling lilly notwithstanding, not only because the FDA is an agency upon which no real reliance can be based but also because of the delays and costs associated with efficacy testing to the standards by which the FDA assesses a pharmaceutical product as "effective."

I suspect that neither lilly nor her husband, PharmDoc, has any experience with the methods and usages of the FDA, else our lovely lilly wouldn't say anything as friggin' stupid as:

"Jesus Christ, do you really think that efficacy should not be a standard in drug marketing??

Not if you rely on the FDA to set that standard, Mrs. lilly.

The FDA's Office of New Drugs (OND) can be - and commonly *IS* - "gamed" to the max by pharma companies, big and small.

Their corporate officers (whom I despise) have great incentive to do so, and devote literally billions of their stockholders' money to that end.

Look, lilly, let me give you a hint.

You can trust the FDA's integrity and efficacy as an overwatch authority when they begin to appoint as Commissioner "no-name" professionals like Dr. David Graham, the guy who blew the whistle on the Vioxx safety studies in 2004 rather than high-profile slurpers who can be counted upon to serve as performing dogs rather than rigorous guardians of the public health.


--
"[L]ike all monopolies, the FDA must limit the amount of information consumers have in order to perpetuate its control. A key to the FDA's power has been its ability to limit consumer information about the relative risks and benefits of drugs. The proof of efficacy requirements were added because critics of the pharmaceutical industry regarded much drug development as overly profitable."

-- Robert M. Goldberg; see http://www.cato.org/pubs/regulation/reg18n2c.html

Thieves
Any time that someone spends money (especially hundreds of millions of dollars) to create a facility and then more money (again, many millions of dollars) to create the drug itself, it is only reasonable that they would be able to patent what they make so they can recoup the money they have invested. For a given period of time, they 'own' the drug.

How many people would go out a buy a brand new car just so they can bring it home and give the keys to someone else that did not invest the money to purchase it themselves?

Patent infringement robs the developing company of their investment by STEALING their rightful returns.

BTW, pharma profits are not accurately stated because there are many investments in drug research that do not pay off. For every drug that makes it to market, probably 50 were started on the path of research that did not make it to market.

Onceamarine
I would like you to know that during the nearly 30 years my husband served as an officer of the Food and Drug Administration, not only did he not accept so much as a free aspirin but it was very much not in the culture for anyone else to do this either. It was clearly understood that freebies from companies were a no-no. Now, I can't say; he has been retired for twenty years. I will say that before he left the anti-regulatory winds had started to blow a gale and the Zeitgeist was that companies could regulate themselves, arguably one of the stupidest statements ever made, and judging from the pay-to-play that has been going on in DC in the past eight years, I would believe anything. But during the years of my husband's tenure, it definitely was NOT normative for FDA executives to be "in bed" with drug companies. There was never a shortage of agency gossip, who was sleeping with whom, all that sort of thing, but one simply did not hear that much about payola. I recall one example when somebody sold out to a drug company for a $500 gift certificate to Raleigh's, a clothing store, and all the talk was about the colossal idiocy of a man who would sell his honor for such a price. Another time at an out-of-town conference a female company rep knocked on my husband's hotel room door at night and told him her company had instructed her to give him anything he wanted (he thanked her and said he didn't need anything).

It's fashionable now to say that government employees are all crooked, stupid, and lazy. Don't believe everything you hear.

SJDoc
I will convey your message to my dear one in he morning as he has gone to bed. Re drug efficacy: although I myself am not a scientist, I read the English language fairly well, and I remember the drug ads in the facsimile copy of the 1910 Sears catalog we used to have around the house. It was loaded with ads for nostrums guaranteed to cure cancer, female trouble, dyspepsia, tuberculosis, sadness, warts, impotence, colic, typhoid, and the pain of babies cutting teeth---usually the same medicine was recommended for multiple indications. A public policy of free market, no regulation, and no drug efficacy standard would quickly take us back in time to those exciting days.

As a regular patron of townhall I understand that some among us would like a world with no speed limits, no Equal Opportunity, no clean air standards, no nutrition labels on groceries, and no inspection of meat or seafood (in short, a world without government). But your suggestion is uniquely blood-curdling: no drug efficacy standards. Just let anybody market any substance he wants and make any therapeutic claim for it, and let the buyer beware. And, BTW, my husband is not naive to the ways of the FDA; he was with the agency at Crystal City and a good many years at Fishers Lane.

Lovely lilly - 30 years in the FDA
--
Then your husband, at least, has no excuse for illusions about the purposes (and the history) of FDA standards for the establishment of efficacy in specific indications, or the costs that are associated with meeting the OND's requirements for satisfying said standards.

Your own ignorance is understandable, though your reference to a 1910 Sears catalog is a remarkable demonstration of the abysmal *DEPTHS* of that ignorance. The marketing of prescription drugs had moved along from that level while my mom was writing V-mail to my dad "somewhere in the Pacific."

Clinical assessment of safety, tolerability, and efficacy continues in areas *outside* FDA-approved indications even when a pharmaceuticals marketer is not pursuing approval for sNDA applications (i.e., permission to market in those presently "off-label" therapeutic areas).

As long as a drug is approved for any indication, it can be used in ethical Phase IV studies as the clinical investigators desire, and these investigators need not be funded by the pharma companies while undertaking these structured trials.

There is ample reason, however, for the patent-holders (and NDA applicants) to undertake such trials of efficacy even without regulatory requrement, and that's the need to establish the utility, cost-benefit and risk-benefit characteristics of their products.

To the satisfaction of prescribers and patients alike. The criminal statutes regarding the crime of fraudulent advertising, if enforced (and not "safe harbored" by the FDA's regulatory approvals) suffice as protection.

This is the free market at work, rather than the structured (and profoundly unsatisfactory) political regulatory environment on which you blindly dote.

--

The cost of developing new drugs
would be greatly reduced if there weren't hundreds or thousands of taxes imposed on every step of the development process.
Sign Up to Post Your CommentsSign Up to Post Your Comments
If you are already registered, click here to login. Otherwise, please take a few seconds to register with Townhall.com. Once you sign up, you’ll be able to post your comments immediately, use the action center, get podcasts, and more!
Note: Fields marked with a red asterisk (*) are required.
Salutation:
First Name:
*
Last Name:
*
Email:
*
Nickname:
*
Note: Nick name will be shown when you post comments.
Address 1:
*
Address 2:
City:
*
State:
*
Zip:
*
Phone:
      
Your daily must-read of conservative columns, cartoons and news. Coulter, Sowell, Krauthammer and more.
(Bi-Weekly) We highlight the best opportunities from our partners for surveys, action items and more.