The History of Drug The History of Drug Therapy in AmericaTherapy in America

Source: The $800 Million Pill: Source: The $800 Million Pill: The Truth behind the Cost of The Truth behind the Cost of

New DrugsNew Drugs

Early BeginningsEarly Beginnings

Roosevelt was re-electedRoosevelt was re-electedin 1936; but his personalin 1936; but his personalLife was challenged withLife was challenged withThe fever of his son,The fever of his son,FDR Jr. who had TonsillitisFDR Jr. who had Tonsillitis*The infection seeped *The infection seeped Into the blood which in Into the blood which in Those days, “fatal”.Those days, “fatal”.

George Tobey Jr. George Tobey Jr. White House PhysicianWhite House Physician Tobey administered a Tobey administered a

German drug called, German drug called, Protosil, Protosil, which was a which was a derivative of a derivative of a chemical dye cure; chemical dye cure; used in the treatment used in the treatment of bacterial infections.of bacterial infections.

FDR Jr. recovered and FDR Jr. recovered and the New York Times the New York Times proclaimed this event proclaimed this event as the new era of as the new era of Wonder DrugsWonder Drugs

Wonder Drug EraWonder Drug Era

Prontosil ushered in an Prontosil ushered in an era of drug therapy and era of drug therapy and “Drug Marketing”“Drug Marketing”

Prior to this, Depression-Prior to this, Depression-era Pharmaceuticals were era Pharmaceuticals were a sprinkling of small firms a sprinkling of small firms peddling a handful of peddling a handful of cures (1930 symposium cures (1930 symposium listed only seven diseases listed only seven diseases they could affect)they could affect)

The Bayer CorporationThe Bayer Corporation

1932 – German 1932 – German Gerhard Domagk in Gerhard Domagk in Elberfeld, Germany Elberfeld, Germany (developed one of (developed one of the first drugs for the first drugs for the treatment of the treatment of Syphilis), treated a Syphilis), treated a cured white mice cured white mice from streptococcus from streptococcus with a red dye with a red dye derivative.derivative.

The agent which wasThe agent which was

Responsible for the cureResponsible for the cure

Was not the “dye”; butWas not the “dye”; but

A chemical called,A chemical called,

Sulphanilamide” Sulphanilamide” which which

Was activated once the original Was activated once the original medication was metabolizedmedication was metabolized

Hitler called the Hitler called the drug, “quackery” drug, “quackery” and forced and forced Domagk, in 1939, Domagk, in 1939, to refuse the Nobel to refuse the Nobel Prize for chemistryPrize for chemistry

Enter the Era of Sulfa DrugsEnter the Era of Sulfa Drugs Many countries began Many countries began

developing their own developing their own version of the sulfa version of the sulfa drug…these were called drug…these were called “me-too” medications.“me-too” medications.

In 1937, a small In 1937, a small Tennessee Corporation Tennessee Corporation called Massengill called Massengill started making a liquid started making a liquid form for Southerners form for Southerners and children, b/c they and children, b/c they believe these folks liked believe these folks liked it that wayit that way

““Me-Too”Me-Too”

Sulfa did not dissolve in water or Sulfa did not dissolve in water or alcohol, the company suspended it in alcohol, the company suspended it in diethylene glycol, an industrial diethylene glycol, an industrial solvent used to make antifreeze.solvent used to make antifreeze.

No on thought to test the product No on thought to test the product before putting it on the market..100 before putting it on the market..100 people died (mostly children). The people died (mostly children). The President did not take any President did not take any responsibility and the chief chemist responsibility and the chief chemist committed suicide.committed suicide.

““Me-too”Me-too”

The 1906 Pure Food and Drug The 1906 Pure Food and Drug Act was subsequently altered Act was subsequently altered (originally designed for the (originally designed for the prevention of selling prevention of selling contaminated food).contaminated food).

For the first time, the newly For the first time, the newly created FDA made drug created FDA made drug companies prove their companies prove their products were safe for human products were safe for human consumption.consumption.

Result was the Result was the Drug Companies Drug Companies peddling their peddling their wares to the wares to the Doctors.Doctors.

With all this With all this competition, the competition, the price of sulfa drugs price of sulfa drugs plungedplunged

For Example:For Example:

The first miracle antibiotics The first miracle antibiotics which came along which came along following WW II had been following WW II had been massed produced by the massed produced by the government (penicillin for government (penicillin for wartime efforts); were wartime efforts); were licensed to five firms who licensed to five firms who engaged in fierce engaged in fierce competition and from 1945 competition and from 1945 to 1950 the price of to 1950 the price of penicillin fell from $3,955 penicillin fell from $3,955 to $282 a poundto $282 a pound

Next Generation of Next Generation of AntibioticsAntibiotics

Late 1940, Selman Late 1940, Selman Waksman of Rutgers Waksman of Rutgers U. developed U. developed streptomycin which streptomycin which was the first effective was the first effective treatment for treatment for tuberculosis.tuberculosis.

Earned a Nobel Prize Earned a Nobel Prize and was America’s and was America’s most celebrated most celebrated research scientist in research scientist in the late 1940’sthe late 1940’s

Jonas SalkJonas Salk

Developed the first Developed the first polio vaccine in the polio vaccine in the mid-1950’s and mid-1950’s and refused to patent refused to patent the vaccine the vaccine

…….But Selman…..But Selman….

Patented the streptomycin and licensed Patented the streptomycin and licensed it to the Merck Research Laboratoriesit to the Merck Research Laboratories

THIS WAS A WATERSHED EVENT IN THE THIS WAS A WATERSHED EVENT IN THE EVOLUTION OF THE DRUG INDUSTRY EVOLUTION OF THE DRUG INDUSTRY FOR THE FIRST TIME THE PATENT AND FOR THE FIRST TIME THE PATENT AND TRADEMARK OFFICE (PTO) GAVE A 17 TRADEMARK OFFICE (PTO) GAVE A 17 YEAR EXCLUSIVITY MONOPOLY TO A YEAR EXCLUSIVITY MONOPOLY TO A PRODUCT IN ITS RAW STATE HAD BEEN PRODUCT IN ITS RAW STATE HAD BEEN PART OF NATURE……..PART OF NATURE……..

BACKLASHBACKLASH

Merck was worried about Merck was worried about the public’s response to the public’s response to generating massive profits generating massive profits so Merck returned the so Merck returned the license for streptomycin to license for streptomycin to the nonprofit Rutgers the nonprofit Rutgers Research Foundation and Research Foundation and the drug was sold broadly the drug was sold broadly and generically…it fell to and generically…it fell to rock bottom prices like rock bottom prices like the penicillin story.the penicillin story.

AntibioticsAntibiotics The government took a “hands-off” The government took a “hands-off”

approach after that and no other approach after that and no other licenses were distributed to other licenses were distributed to other companies and so the antibiotic companies and so the antibiotic development field became controlled by development field became controlled by few companies and the new antibiotic few companies and the new antibiotic prices skyrocketed.prices skyrocketed.

The Antibiotic Cartel The Antibiotic Cartel InvestigationsInvestigations

Federal Trade Commission was Federal Trade Commission was concernedconcerned

About lack of competition among Drug About lack of competition among Drug Companies…Companies…

*In the 1950’s, Drug Companies were *In the 1950’s, Drug Companies were discovering class after class of new discovering class after class of new medicines including antidepressants, medicines including antidepressants, antacids, anti-inflammatories, antacids, anti-inflammatories, antihistamines, and new drugs to antihistamines, and new drugs to control blood pressurecontrol blood pressure

CopyCatsCopyCats

Whenever a new drug was found, Whenever a new drug was found, other firms introduced copycat other firms introduced copycat versions of the original molecule versions of the original molecule within a very short time.within a very short time.

These copycats or “me-too” drugs These copycats or “me-too” drugs would enter the market place at the would enter the market place at the same or within a few percentage same or within a few percentage points of the innovator’s pricepoints of the innovator’s price

Enter Senator Estes Kefauver Enter Senator Estes Kefauver of Tennesseeof Tennessee

A Yale-trained lawyer who A Yale-trained lawyer who was a fast-tracker because of was a fast-tracker because of this hearings on the Mob and this hearings on the Mob and gamblinggambling

Held a series of hearings from Held a series of hearings from 1960-62 evaluating the price 1960-62 evaluating the price fixing of the Drug Companiesfixing of the Drug Companies

What came of the hearings is What came of the hearings is that the companies had to that the companies had to prove the drugs were not only prove the drugs were not only safe, but effectivesafe, but effective

1935-1960’s 1935-1960’s First Great Era of Drug First Great Era of Drug

DiscoveryDiscovery

The era of Molecular ModificationThe era of Molecular Modification Produced by late 60’s more than 200 sulfa drugs; Produced by late 60’s more than 200 sulfa drugs;

more that 270 antibiotics; 130 antihistimines and more that 270 antibiotics; 130 antihistimines and 100 major tranquillizers100 major tranquillizers

THE KEY: NEW DRUGS OFFER THE PHYSICIAN AND PATIENT NO SIGNIFICANT CLINICAL ADVANTAGES BUT ARE DIFFERENT ENOUGH TO WIN A PATENT AND THEN BE MARKETED USUALLY AT THE IDENTICAL PRICE OF THE PARENT PRODUCT OR EVEN A HIGHER PRICE.

1970’S-1980’S1970’S-1980’SERA OF CELLULAR ERA OF CELLULAR

INTERACTIONSINTERACTIONS A Second wave of drug A Second wave of drug

innovationinnovation Drawing upon the Drawing upon the

governments involvement governments involvement in disease after WW II in disease after WW II (NIH), researcher (NIH), researcher promised cures for chronic promised cures for chronic conditions that had conditions that had become the leading become the leading causes of death…heart causes of death…heart disease, cancer, diabetes disease, cancer, diabetes and dementiaand dementia

New Drugs included:New Drugs included:

1. Angiotensin Converting Enzymes 1. Angiotensin Converting Enzymes (ACE for Blood Pressure)(ACE for Blood Pressure)

2. Statins for lowering cholesterol2. Statins for lowering cholesterol 3. Anti-depressants3. Anti-depressants 4. Antacids4. Antacids 5. Antihistimines5. Antihistimines 6. Calcium Channel Blockers6. Calcium Channel Blockers 7. Erectile Dysfunction Drugs7. Erectile Dysfunction Drugs

By the 1990’sBy the 1990’s

Leading pharmaceutical companies were Leading pharmaceutical companies were basically producing comparable productsbasically producing comparable products

Market was divvyed up; but their was no Market was divvyed up; but their was no competition on pricescompetition on prices

Result: Drug prices, like health care Result: Drug prices, like health care generally, were soaring at double-digit generally, were soaring at double-digit pricesprices

Came under public scrutiny – “me-too” Came under public scrutiny – “me-too” practices were being called into questionpractices were being called into question

Pharmaceutical Rationale…Pharmaceutical Rationale…

Not copycat or “me-too” drugs but rather Not copycat or “me-too” drugs but rather these drugs had fewer side-effects than these drugs had fewer side-effects than their predecessorstheir predecessors

No such thing as “one-size fits all” drugNo such thing as “one-size fits all” drug ““Each patient is unique and may respond Each patient is unique and may respond

to the same drug differently. What works to the same drug differently. What works for one person does not necessarily work for one person does not necessarily work for another. Physicians and patients for another. Physicians and patients benefit from a variety of medicines benefit from a variety of medicines available to treat each ailment.”available to treat each ailment.”

Clinton Administration (1993-4) Clinton Administration (1993-4) was not impressedwas not impressed

Of the 127 new Of the 127 new drugs approved drugs approved between 1989-between 1989-1993, David 1993, David Kessler of the FDA Kessler of the FDA only a few offered only a few offered a clear clinical a clear clinical advantage over advantage over existing therapies.existing therapies.

For Patients and For Patients and Providers???Providers??? This can lead to misleading This can lead to misleading

promotions, conflicts of interest, promotions, conflicts of interest, increased costs for health care increased costs for health care and inappropriate prescribing.and inappropriate prescribing.

Example: Stomach Acid Example: Stomach Acid Wars of the 1990’sWars of the 1990’s

Chronic condition went far beyond non prescriptive acid neutralizers that can be purchased anywhere in in almost every form imaginable, from crunchy tablets to chalky liquids

Stomach WarsStomach Wars

Stomach ulcersStomach ulcers Reflux diseaseReflux disease Erosive EsophgitisErosive Esophgitis

Stomach WarsStomach Wars

Originally, used Originally, used HISTAMINES.HISTAMINES. In 1937 Diphehydramine or

BENADRYL was discovered. (Which also provided the chemical basis for the wildly popular antidepressant, FLUOXETINE or PROZAC)

First to do studies on First to do studies on Histamines>>Histamines>>

James Black of Smith, Kline and FrenchJames Black of Smith, Kline and French He had developed the first drugs that He had developed the first drugs that

could block adrenaline’s effect on the could block adrenaline’s effect on the heart by identifying two receptors (alpha heart by identifying two receptors (alpha and beta) that bound to adrenaline (heart and beta) that bound to adrenaline (heart only has one receptor – the beta)only has one receptor – the beta)

His team developed the first beta-blocker, His team developed the first beta-blocker, PROPRANOLOL (A MAJOR PROPRANOLOL (A MAJOR BREAKTHROUGH IN BP AND HEART BREAKTHROUGH IN BP AND HEART DISEASE)DISEASE)

Black applied same concept to Black applied same concept to the stomach…..the stomach…..

Some 700 drugs later, Black found the drug Some 700 drugs later, Black found the drug that blocked the Histamine receptor…that blocked the Histamine receptor…TAGAMET TAGAMET (Cimetidene)(Cimetidene)

Others jumped on the bandwagon with Glaxo Others jumped on the bandwagon with Glaxo producing Ranitidine or producing Ranitidine or ZANTACZANTAC

(similar but of course had fewer side (similar but of course had fewer side effects)..became the best selling drug in the effects)..became the best selling drug in the world.world.

While Black concentrated on While Black concentrated on the acid blocking others took a the acid blocking others took a

different approach…different approach… Others concentrated Others concentrated

on the actual engines on the actual engines in the stomach cells in the stomach cells that produced the that produced the acid…George acid…George Sachs…looked at the Sachs…looked at the Acid Pump as the Acid Pump as the target..developed the target..developed the drug drug OMEPRAZOLE OMEPRAZOLE or PRILOSECor PRILOSEC

By the 1990’s, Antacid sales in the By the 1990’s, Antacid sales in the U.S. were over $7 Billion (Merck #1)U.S. were over $7 Billion (Merck #1)

The proton-pump inhibitor, PRILOSEC, The proton-pump inhibitor, PRILOSEC, became the best-selling medicine in became the best-selling medicine in the world (By 2000, it had U.S. Sales the world (By 2000, it had U.S. Sales of $5 Billion)of $5 Billion)

TAP Pharmaceutical’s “me-too” proton TAP Pharmaceutical’s “me-too” proton pump drug, PREVACID - $3 Billionpump drug, PREVACID - $3 Billion

Along came Barry Marshall of Along came Barry Marshall of the Royal Perth Hospital of the Royal Perth Hospital of

AustraliaAustralia Marshall isolated a Marshall isolated a

bacterimmbacterimm

Called Helicobacter PyloriCalled Helicobacter Pylori

MarshallMarshall His approach to stomach ulcers, gastritis His approach to stomach ulcers, gastritis

and stomach cancer was this bacteria, and stomach cancer was this bacteria, which infects one half of the world’s which infects one half of the world’s populationpopulation

MarshallMarshall

No Drug Company would champion a No Drug Company would champion a solution that could be handled with solution that could be handled with short, cheap course of generic short, cheap course of generic antibiotics when they were making antibiotics when they were making millions treating chronic recurrences millions treating chronic recurrences with expensive prescription antacids.with expensive prescription antacids.

What was the Response??What was the Response??

Instead of pursuing this potential cure for Instead of pursuing this potential cure for ulcers, companies like ASTRA; the ulcers, companies like ASTRA; the producers of PRILOSEC came up with producers of PRILOSEC came up with OPERATION SHARK FINOPERATION SHARK FIN

An effort to fund a drug to replace An effort to fund a drug to replace PRILOSEC after it came off patent and PRILOSEC after it came off patent and became generically available.became generically available.

They tried Drug combinations and oral They tried Drug combinations and oral suspensions but they came up with a suspensions but they came up with a molecule that was in essence, HALF OF molecule that was in essence, HALF OF PRILOSEC…and called it NEXIUMPRILOSEC…and called it NEXIUM

This allowed them to extend This allowed them to extend the Patentthe Patent

It is a quirk of the It is a quirk of the chemistry of organic chemistry of organic moleculesmolecules

Most organic Most organic molecules come in molecules come in two shapes because two shapes because their carbon atoms their carbon atoms arrange themselves arrange themselves in six sided rings.in six sided rings.

The side chains of atoms that make The side chains of atoms that make the molecule unique can attach the molecule unique can attach themselves to either side of the themselves to either side of the symmetrical ringssymmetrical rings

The result is a The result is a mixture of two mixture of two versions of the versions of the molecule, each with molecule, each with the same chemical the same chemical formula, but different formula, but different in that they are mirror in that they are mirror images of each other; images of each other; much like a person’s much like a person’s left and right hands.left and right hands.

Each version is called Each version is called an ENANTIOMER or an ENANTIOMER or ISOMERISOMER

Sometimes only Sometimes only one ISOMER is one ISOMER is active against active against disease. The other disease. The other is inactive or causes is inactive or causes unwanted side unwanted side effects.effects.

Drug Companies Drug Companies separated the two separated the two sidessides

(Nobel Prize for (Nobel Prize for Chemistry in 2001 – Chemistry in 2001 – Sharpless, Noyori, Sharpless, Noyori, KnowlesKnowles

This new process succeeded in This new process succeeded in rescuing some drugs that had been rescuing some drugs that had been shelved due to side effectsshelved due to side effects

TERFENADINE OR SELDANE (Merrell TERFENADINE OR SELDANE (Merrell Dow, later Aventis)Dow, later Aventis)

(non-sedating anti-histimine originally (non-sedating anti-histimine originally caused heart palpitations…It is caused heart palpitations…It is known today as ALLEGRA…known today as ALLEGRA…

Operation Shark FinOperation Shark Fin

Nexium was nothingNexium was nothing

more than Pilosec’s more than Pilosec’s

Isomers. Getting rid of half the drug Isomers. Getting rid of half the drug would provide no beneficial effects would provide no beneficial effects for the patient. Yet the FDA approved for the patient. Yet the FDA approved it because one-half the old entity was it because one-half the old entity was a new entity.a new entity.

Nexium and Prilosec Nexium and Prilosec (cont’d)(cont’d)

The Astra Corporation still needed The Astra Corporation still needed more evidence to support the new more evidence to support the new drug. They funded four studies on drug. They funded four studies on erosive esophagitis. The slower erosive esophagitis. The slower metabolizing Nexium healed 90% after metabolizing Nexium healed 90% after eight weeks; while the Prilosec healed eight weeks; while the Prilosec healed 87% after the same time span. Two of 87% after the same time span. Two of the studies showed no difference and the studies showed no difference and were never release to the public.were never release to the public.

Prilosec and Nexium Prilosec and Nexium (cont’d)(cont’d)

In 2001, Nexium hit the market with In 2001, Nexium hit the market with “detailers” pushing the drug with a “detailers” pushing the drug with a massive television campaign. The massive television campaign. The company (now Astra Zeneca) used its company (now Astra Zeneca) used its lawyers to block the generic drug from lawyers to block the generic drug from the marketplace while convincing the the marketplace while convincing the FDA to allow Prilosec onto the over-the-FDA to allow Prilosec onto the over-the-counter (OTC) market; thus frustrating counter (OTC) market; thus frustrating the generic manufacturers and giving the generic manufacturers and giving Nexium free rein as the prescription Nexium free rein as the prescription antacid!antacid!

The 1990’s PracticeThe 1990’s Practice Billions of dollars poured into Billions of dollars poured into

research to develop research to develop alternatives to drugs that alternatives to drugs that were approaching the end of were approaching the end of their patent terms.their patent terms.

In most cases the In most cases the alternatives were little alternatives were little changed from the originals.changed from the originals.

The better the original the The better the original the more the possibility of more the possibility of generating a copycat version generating a copycat version with renewed patent life.with renewed patent life.

ClaritinClaritin

Schering-Plough’s CLARITIN, an anti-Schering-Plough’s CLARITIN, an anti-allergy medication was a allergy medication was a nonsedating alternative to an earlier nonsedating alternative to an earlier generation of antihistamines.generation of antihistamines.

By late 1990’s generated over $2 By late 1990’s generated over $2 Billion annuallyBillion annually

Claritin was on the verge of Claritin was on the verge of making even more money. making even more money.

Why?Why? 1997 legislation legalized direct to 1997 legislation legalized direct to

consumer advertisingconsumer advertising

Claritin (cont’d)Claritin (cont’d)

Consumers were Consumers were encouraged to ask their encouraged to ask their physician for a month’s physician for a month’s supply for $80.00 despite supply for $80.00 despite the fact that it worked only the fact that it worked only slightly better than the slightly better than the placebo.placebo.

It is such a low dose with It is such a low dose with only 43-46% of Claritin only 43-46% of Claritin users gaining relief as users gaining relief as compared to the sugar pillcompared to the sugar pill

Claritin/CarcinogenClaritin/Carcinogen

CLARITIN or LORATADINE had to CLARITIN or LORATADINE had to prolong its introduction until 1993 prolong its introduction until 1993 until the results were in……..BUT…..until the results were in……..BUT…..

Those on SELDANE and HISMANAL Those on SELDANE and HISMANAL (other non-sedating antihistamines) (other non-sedating antihistamines) began turning up in emergency began turning up in emergency wards complaining of chest pain wards complaining of chest pain from other interactions.from other interactions.

With other anti-histamines With other anti-histamines being suspect, CLARITIN being suspect, CLARITIN

moved to #1 moved to #1

The old Tactic was reused…The old Tactic was reused…

Just before CLARITIN was to lose its Just before CLARITIN was to lose its patent, the drug was redesigned as patent, the drug was redesigned as DESLORATADINE, thus keeping the DESLORATADINE, thus keeping the patent; and CLARITIN was put OTC patent; and CLARITIN was put OTC again frustrating the generic again frustrating the generic protagonists.protagonists.

Searle’s CELEBREX and Searle’s CELEBREX and Merke’s VIOXXMerke’s VIOXX

2001..Parmacia came up with 2001..Parmacia came up with BEXTRABEXTRA

History - Cox-2 InhibitorsHistory - Cox-2 Inhibitors

Philip Needleman, of the Washington Philip Needleman, of the Washington University Schools of Medicine in St. University Schools of Medicine in St. Louis believed there must be a specific Louis believed there must be a specific enzyme that caused inflammation and enzyme that caused inflammation and pain around the arthritic joints and pain around the arthritic joints and traumatic injuries. traumatic injuries.

It was well known that the enzyme It was well known that the enzyme called cyclo-oxygenase or COX for short, called cyclo-oxygenase or COX for short, triggered the production of triggered the production of prostaglandins which in turn caused prostaglandins which in turn caused swellingswelling

Aspirin, Naproxen or Ibuprofen are Aspirin, Naproxen or Ibuprofen are Non-steroidal Anti-inflammatory Non-steroidal Anti-inflammatory (NSAID’s) drugs which reduce the (NSAID’s) drugs which reduce the pain by blocking the action of COX pain by blocking the action of COX and limiting the production of and limiting the production of prostaglandins.prostaglandins.

Needleman believed there were two Needleman believed there were two types of COX and developed the types of COX and developed the “Super-aspirins”.“Super-aspirins”.

The medical selling The medical selling point of COX-2 point of COX-2 inhibitors was that inhibitors was that it would avoid the it would avoid the development of development of stomach ulcers. stomach ulcers. They marketed a They marketed a campaign against campaign against NSAID’sNSAID’s

COX-2 Drugs netted $3.5 COX-2 Drugs netted $3.5 Billion annually.Billion annually.

Two Question Emerged…Two Question Emerged…

A. Were the A. Were the traditional NSAID’s traditional NSAID’s really as dangerous really as dangerous as a growing as a growing volume of medical volume of medical reports claimed?reports claimed?

And did the Cox-2 And did the Cox-2 inhibitors solve the inhibitors solve the problem?problem?

After “Face Testing” the After “Face Testing” the validity of the extrapolation validity of the extrapolation

studiesstudies The claims were The claims were

greatly greatly overestimated with overestimated with less than 2% of all less than 2% of all NSAID users NSAID users suffering G-I suffering G-I problems.problems.

Problems with COX-2 Problems with COX-2

Vioxx was Vioxx was developing heart developing heart problems and did problems and did not have the same not have the same Cardiovascular Cardiovascular benefits as the benefits as the NSAID’s!NSAID’s!

Celebrex had Problems..Celebrex had Problems..

Its studies were Its studies were replicated and the replicated and the findings were “junk findings were “junk science”.science”.

What do we learn from all What do we learn from all this?this?

By 2004, there were 52 drugs with more By 2004, there were 52 drugs with more than $1 Billion in sales of which 42 were than $1 Billion in sales of which 42 were slated to lose their patient protection by slated to lose their patient protection by 2007. 2007.

Instead of looking for generics or new Instead of looking for generics or new drugs the emphasis is “new and drugs the emphasis is “new and improved”improved”

71.4% of Drug Companies Budget or 71.4% of Drug Companies Budget or $15.7 Billion spent on direct consumer $15.7 Billion spent on direct consumer adsads

Drug Prices will remain highDrug Prices will remain high Generics will be limitedGenerics will be limited We must rely on alternative approaches to We must rely on alternative approaches to

taking drugstaking drugs Drug Company claims are biased (We can Drug Company claims are biased (We can

rely upon their information as much as we rely upon their information as much as we can depend upon a beer company to teach can depend upon a beer company to teach us about alcoholism)us about alcoholism)

Important drugs do not need promotion; Important drugs do not need promotion; but “me-too” drugs do.but “me-too” drugs do.