Why doesn't everyone know about the benefits of a clean nose?

Of course there are several factors responsible, but first off this spray is rapidly becoming accepted. Either this year, 2004, or next it will likely become the highest selling single item in health food stores in America. Why many doctors are not familiar with it is best explained by analogy.

Scurvy is caused by a vitamin C deficiency and used to be a significant problem for sailors because fruit would not keep for the duration of the voyages. The British were the first maritime power to incorporate the use of citrus fruits to prevent this problem. It earned their sailors the nickname of "limeys." But accepting such a change took a long long time.

The first British captain to look at preventing scurvy was James Lancaster. In 1601 he took four ships from England to India. He gave the crew of one ship three teaspoons of lemon juice every day. Half way through the voyage none of these sailors died, compared with 40% of the 278 other crew members. But nothing changes with these startling findings. One hundred and forty six years later (1747) James Lind did a similar study with several different remedies; finding the best to be citrus juice. He wrote the results of his experience in A Treatise on Scurvy that was published in 1753. Still nothing changed until 48 years later (1795), when Gilbert Blane made the use of oranges and lemons in the British Navy mandatory and scurvy was dramatically reduced. But it took yet another 70 years (1865) before the merchant marine followed suit.

Why the lack of interest in such a simple treatment, both then and now?

It is hard to see into people's motives. Certainly changing the way we think and accepting the fault of our wrong headed practices is difficult. But there also may be economic factors: 

Sailors were not paid until return to home port. If 40% of them died before returning home that translated into more profit for the shippers. 

Even with lives at stake change is hard, and even harder if it costs.

There were no economic reasons to change.

Until the end of the 17th Century crews for naval vessels were obtained by press gangs (England) and conscription (France), but such crews had more value because the family or the manor was paid for the seaman's time even if he died. And healthy manpower was of value when it came to battles. Further investment into the sailor occurred in 1835 when Sir James Graham imposed the rule that no pressed man could be required to serve more than 5 years. 

In 1853 employment in the Navy became the standard. The Navy, which had spent some time and money training sailors, and had an investment in them, was the first to change.

The situation today is not that different: 

Large companies that pollute the streams from which we drink and the air that we breathe lobby heavily against mandated restraints against such pollution, even though lives are in the balance. 

In a perverse argument tobacco lobbyists recently pointed out the savings that would accrue to the Czech government from the early death of smokers that would thus decrease the government's social spending: "When people smoke," they pointed out, it's "good for the economic balance in a country." 

The situation is not that different in health care: 

 Brent James M.D., quality improvement officer for Intermountain Health Care, says:  “The system is perverse. . . .The payments are perverse. It pays us to harm patients, and it punishes us when we don’t."

On March 10th 2004 Jerry Pappert, Attorney General for the state of Pennsylvania, sued 13 major drug companies for entering into a complex scheme to artificially inflate the costs of their drugs.

Economics matters when the goal is profits!

Fortunately communication is much better today than it was 300 and 400 years ago and more people that count, the patients themselves, are finding out about the perverseness of the system and realizing the benefits of honoring our own defenses rather than blocking them.

More on the perverseness of our system is at Common Sense Medicine. 

Science. 1981 Feb 27;211(4485):881-6.

Innovation and evaluation.
Mosteller F.
Social, medical, and technological innovations are discussed, first with reference to historical examples and then with modern studies. I show the need for evaluating both the innovations themselves and the research processes leading to them. I suggest some kinds of research that need to be carried out if we are to continue to have a vigorous program of scientific and technological innovation. Finally, I explain the new initiative by the AAAS in science and engineering education.

Abelson, Reed. “Hospitals say they’re Penalized by Medicare for Improving Care.” New York Times. Dec. 5, 2003.

http://fctc.org/archives/news382.shtml      Accessed 4 March, 2004

Issued: Wednesday, March 10, 2004
Contact: 717-787-5211

HARRISBURG - In an effort to curb the skyrocketing costs of prescription drugs in Pennsylvania, Attorney General Jerry Pappert today sued 13 major pharmaceutical companies accusing them of unlawful and deceptive pricing and sales practices in a complex scheme to raise drug prices and capture market share by artificially inflating the cost of their drugs, some of which were used by cancer patients and others with life-threatening illnesses.

"This scheme cost our citizens and the Commonwealth hundreds of millions of dollars in overcharges for prescription drugs," Pappert said at a news conference. "I am seeking to return those dollars to consumers and state programs, put a stop to these practices and thereby lower the cost of prescription drugs for all of us."

Pappert said the 42-page lawsuit, filed today in Commonwealth Court, accuses the drug companies of participating in an unfair and deceptive marketing scheme and conspiracy that provided improper incentives to medical providers to gain market share. The lawsuit alleges that the scheme forced consumers and state agencies to pay significantly higher prices for prescription drugs as drug companies purposefully inflated the cost of those drugs.

Pappert explained that many Pennsylvania consumers purchase drugs, either by themselves or through a health plan or insurer, and are financially harmed when drug companies intentionally raise the prices of their drugs to manipulate the market. Pappert said many older Pennsylvanians, under the federal Medicare program, pay 20 percent of the cost of their drugs and thus also pay more for prescription drugs when the drug companies raise their prices.

In addition, Pappert said, Commonwealth programs and agencies that purchase drugs, including Medicaid, the Pharmaceutical Assistance Contract for the Elderly (PACE) and the Pennsylvania Employees Benefit Trust Fund, all pay for prescription drugs based on a price set by the drug companies. When the drug companies intentionally inflate that price, the companies increase the amount paid by the Commonwealth.

Pappert identified the main defendants as: TAP Pharmaceutical Products, Inc.; AstraZeneca; Bayer AG; GlaxoSmithKline, PLC; Pfizer Inc.; Amgen Inc.; Schering-Plough Corporation; Bristol-Myers Squib Company; Johnson & Johnson; Baxter International Inc.; Aventis Pharmaceuticals, Inc.; Boehringer Ingelheim Corporation, and Dey Inc. The lawsuit also lists several subsidiaries and affiliates as defendants. Pappert said he would reserve the right to take action against other companies who participate in similar alleged schemes to defraud consumers.

Pappert said the lawsuit accuses the defendants of four broad actions that constituted their illegal marketing scheme and conspiracy:

-- Establishing and promoting "spreads" between what drug companies actually charge for the drugs and what consumers and state programs are billed for the drugs.

-- Providing free goods and drug samples knowing that consumers and state government would be charged the full price for the products.

-- Providing other financial incentives and inducements, including cash payments and free trips, to promote the sales of their drugs at exorbitant prices.

-- Engaging in efforts to fraudulently conceal and suppress the illegal conduct in an effort to maintain the scheme and conspiracy.

Promotion of "Spreads"

Pappert said the lawsuit accuses drug companies of inflating the "average wholesale price" (AWP) of prescription drugs to create a financial incentive for medical providers to use their drugs over a competitor's drugs. Pappert explained that federal and state programs base their reimbursement rates on the AWP, which in turn is the price charged to private insurers and consumers for prescription drugs.

Pappert said the AWP is supposed to represent the average price that drug companies charge for a drug. In reality, he said, drug companies set the AWPs without basing them on average prices. Pappert added that drug companies often sell drugs to medical providers at costs well below the AWP, creating a "spread" between what a medical provider actually pays for a drug and what that provider charges consumers and state government.

Pappert said the lawsuit accuses drug companies of "competing" on spreads - purposefully inflating the AWP to provide incentives for providers to choose their drugs - in order to capture market share.

"This conduct perverted competition in the marketplace by rewarding companies that charged the most for their drugs," Pappert said. "Competition is supposed to result in lower prices for consumers, not higher prices. This illegal scheme turned that market principle on its head."

In explaining the problem of spreads, the lawsuit provided an example of the prostate cancer drugs Lupron and Zoladex, which are manufactured, distributed, marketed and sold by TAP Pharmaceutical Products and AstraZeneca PLC respectively.

The lawsuit explains that Lupron in the 1990s commanded the greater market share over other prostate cancer drugs, despite the fact that its actual cost traditionally had been much higher. The lawsuit explains that Lupron's AWP was higher than other drugs, giving it a larger spread. The lawsuit alleges that Lupron garnered its large market share because of its high cost, which gives providers a financial incentive to prescribe it.

"Consumers lose when drug companies compete for higher prices," Pappert said.

Provision of Free Goods and Drug Samples

Pappert said the lawsuit also accuses the drug companies of providing free samples to medical providers as another financial incentive for them to choose their products. Pappert said the companies gave the free samples knowing that medical providers would bill consumers and the Commonwealth for the products.

Pappert noted that TAP Pharmaceuticals pleaded guilty to federal conspiracy charges for providing free samples of Lupron to medical providers. As a result of the plea, the company paid more than $890 million in fines and civil penalties to the federal government. However, Pappert noted no Pennsylvania consumers or state programs, with the exception of Medicaid, received reimbursements for the illegal activity.

In addition, Pappert noted, AstraZeneca pleaded guilty to federal conspiracy charges for providing free samples of Zoladex to medical providers. The company paid $345.9 million to the federal government. However, no Pennsylvania consumers or state programs, with the exception of Medicaid, received reimbursements for the illegal activity.

Other Financial Incentives

Pappert said the lawsuit also accuses the drug companies of the widespread practice of offering trips, consulting opportunities, seminars, gifts, meals and cash payments to medical providers in return for prescribing their products.

Fraudulent Concealment

Pappert said the complaint accuses the drug companies of fraudulently concealing the process and methodology used for determining the AWPs. Pappert said the companies also prevented the Commonwealth and consumers from knowing the actual price paid by medical providers for the prescription drugs.

Pappert said the recent federal criminal investigations uncovered a pattern of unlawful conduct by drug companies involving the promotion of spreads and the provision of free goods and samples, but the Commonwealth and consumers did not learn what the spreads currently are and have been for these products.

In the complaint, Pappert asks Commonwealth Court to:

-- Issue a permanent injunction stopping the drug companies from committing the illegal conduct.

-- Return to Pennsylvania consumers and the Commonwealth overpayments for drugs as a result of the scheme and conspiracy during the period the unlawful conduct took place.

-- Award a $1,000 civil penalty for each offense against Pennsylvania consumers under 60 years old and $3,000 for each offense against Pennsylvania consumers 60 years old and older, as required under the Unfair Trade Practices and Consumer Protection Law.

-- Award punitive damages against the drug companies.

-- Require the drug companies to pay attorneys fees, expert witness fees, costs of investigation and other related costs.

Pappert noted that the Commonwealth's litigation will be handled by Kline and Specter, P.C., of Philadelphia. Pappert noted that the lawsuit does not concern the effectiveness or quality of any of the prescription drugs involved in the case.

"As Attorney General, I am committed to doing everything I can to reduce the price of prescription drugs for the Commonwealth and its citizens," Pappert said.

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