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Generic and Open Source Drugs Vs. Brand name drugs

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Juliana Montenegro

on 22 November 2013

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Transcript of Generic and Open Source Drugs Vs. Brand name drugs

Private Property Index
Whats the Problem in Open Source Drug Market ??
History of Production
Outsourcing
Economic Cost
HMO's
Juliana Montenegro
Giselle Dominguez
Terrance Godbold
Robert Lopez

What is the issue with generic drugs?
Two sides:
From the original manufacturers side, they put their labor into the production of the drug so it should belong to them for as long as they want to
From the consumers side, monopolizing and extending patent's duration on drugs will cause a great part of the population to be unable to purchase essential medication

Its absorption rate may be slower due to different non-active ingredients.
Only undergoes a "bioequivalence" test. This test doesn't always uncover serious problems
The labels on generic medications contain the same data as the pharmacokinetics sheets included with the name brand drug, even though the dosages and filler content are entirely different.
Less legal responsibility, cannot be sued
Not all work the same, some have increased risk
Cons of using generic drugs
More companies are able to manufacture and sell them
reduces shortage
Brand-name drugs' price decreases
prices are about 30% to 60 % less than brand-name drugs
saves consumers about $8 to $10 million
reduces health care costs
Pros of using generic drugs
A new drug marketed under a proprietary, trademark-protected name
They have temporary patents that protect their investments by giving the company the sole right to sell the drug while the patents are in effect.
A company hoping to get a single drug to market can expect to have spent $350 million before the medicine is available for sale.
What is a brand-name drug?
What is a generic drug?
The chemical equivalent of a brand-name drug. Its active ingredient(Chemical that makes the drug work) must be the same but inactive ingredients may vary
When the patent of a brand-name drug expires, other pharmaceutical companies are able to produce them
The FDA only requires that generic drugs contain 80 percent to 125 percent of the active ingredients of the brand-name version
They must be identical in strength, dosage form, quality, effectiveness, and route of administration
Cheaper than the brand-name counterpart
What are open source drugs?
Public access platform in which everything is open, so anyone can come along, make molecules, do biology, do informatics, contribute data to the lab notebooks, and generally contribute in any number of ways for which there are simple technological solutions.
All sorts of inputs are possible, including experimental ones.
Content
Generic and brand-name drugs
Open source drugs
The commons
Private property of open source drugs
Production/costs
Moral issue
Questions
The Intellectual Commons: Generic and Open Source Drugs
Whats the Problem in Open Source Drug Market
How is Private Property Regulated
Pantent
Re-Patents
WWLS
WWRS
CBER-Center for Biologics Evaluation and Research

(CBER) is one of six main centers under the U.S. Food and Drug Administration

• Responsible for assuring the safety, purity, potency, and effectiveness of biologics and related products (such as vaccines, live bio-therapeutics (probiotics), blood products, and cell, tissue, and gene therapies

Covers-screening of molecules, lead optimization, identification of drug-able non-toxic targets.
Enables sharing of for collaborative research information, ideas, articles, papers, data, software, applications, results of experiments, patented inventions, etc.

wwld VRS wwrd
One Doctor can claim the ownership of a particular idea of a drug and claim it as his own
False ownership of prescription drugs
Can set up monopolies between pharmaceutical industries, and medical research companies.
Takes away money and funding from companies that do research and lab work.
Overview
How is Private Property Regulated ??
Private property is regulated by development, production, importation, exportation and distribution must be regulated to ensure that they meet prescribed standards.
Examples
Patents
Re-patents
Companies Under the FDA
History
1888-American Pharmaceutical moves to prevent counterfeiting of Branded products.
1906- Congress passed Federal Food & Drugs act-soon to become FDA.
1937-Elixir Sulfanilamide incident
1938-Congress passed Federal Food, Drug, and Cosmetic Act-All drugs after 1938 had to be proven safe through manufacturer testing and approved by FDA.
1957-Medicaid and Medicare amendments to Social Security.
1984-The Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act) is passed. Allows FDA to approve Generic versions of drugs after 1962 without repeating safety and efficacy tests. Increased the availability of cheaper drugs. Increased patent on brand name drugs by 5 years to make up for time lost during approval process.
Patents
Patent- is a set of exclusive rights granted by a sovereign state to an inventor or their assignee for a limited period of time, in exchange for the public disclosure of the invention
Patent lifetime differs from country to country; typically an expired patent cannot be renewed. In the U.S., patent extensions may be granted if changes are made.
Patents in the US last 5-20 years depending on the drug
FDA-Food and Drug Administration
FDA/Restrictions
• FDA- mission is to promote and protect the public health by ensuring that safe and effective drugs are available to Americans
• The agency also has 223 field offices and 13 laboratories located throughout the 50 states
• Started in 1906 by Theodore Roosevelt, used to regulate the safety of drugs and medications.

CBER
OSDD
Elixir Sulfanilamide incident
Open Source Drug Discovery
• Initiative of the Council for Scientific and Industrial Research (CSIR) in India, with international partnerships.
Outsourcing
Economic Costs
HMO's
The Elixir Sulfanimide incident was the turning point in American food and drug history.

Sulfanilamide was used to treat streptococcal infections. It eceived great praise for its curative effects and had been used safely in both tablet and powder form for some time.

In June 1937, a salesman from S.E. Massengill Co., in Bristol, TN., received huge demand for the drug in liquid form. The company’s chemist, Harold Cole Watkins, through trial and error, found that sulfanilamide dissolved best in diethylene glycol. The only tests performed on the new elixir was for flavor, appearance, and fragrance. The company immediately manufactured and sent 633 shipments all over the country.

At the time, drug laws did not require safety testing on new drugs and because none were done on the new elixir, Harold Watkins failed to note Diethylene Glycol as a toxic substance-normally used as an anitfreeze.

The first shipments went out in September. By mid-October, The American Medical Association had received complaints of an unknown elixir causing deaths. The AMA asked for samples and immediately contacted Messengill for further info.
The AMA, through their own analysis, identified Diethylene Glycol as the toxic susbstance and immediately sent out radio and newspaper warnings about the toxicity of Elixir Sulfanilamide. FDA agents were immediately sent to recover the remaining shipments from over 200 locations.
In the end, over 107 men, women, and children had died from ingesting Elixir Sulfanilamide.
Labour creates property, but it also does contain limits to its accumulation
As human populations grow, simple but unstable forms of co-operation evolve around activities
Name-Brand Drug: Wellbutrin (used as an anti-depressant drug)
Generic-Brand Drug- Budeprion
2006- Budeprion was approved by FDA to serve of equal substitute to Wellbutrin.

Generic Drug Recall Example
Shortly after the FDA approved of the generic drug, multiple cases of adverse effects were reported.
worsened depressive symptoms
worsened suicidal tendencies
Budeprion Problems
2010- FDA held tests on Budeprion
Lab Results- generic drug only 86% of the Name-Brand drug which is considered under the standard FDA criteria for bio equivalence.
Drug was than recalled
Budeprion Recalled
Turning over R&D, manufacture of drugs to overseas firms.

Main reason for outsourcing is to cut costs. Second is to find cutting edge technologies capable of manufacturing drugs at low cost.

Recent popularity due to brand name copyrights running their 20 year lifespan.


Court Case
Case Study
Pfizer
Karen Bartlett, suffered horrific injuries after taking a generic version of an anti-inflammatory drug, Sulinduc, for shoulder pain.
Two- Thirds of her skin fell off & she was left blind & disfigured.
By a narrow 5 to 4 margin, the supreme court overturned lower court rulings that had awarded her $21 million for pain and suffering.
Shutdown 2 U.S. plants in Brooklyn, NY and Omaha, NE.

Due to patent expiration on some of their biggest drugs.

Generic drugs moved in and were placed strategically in the market amid the patent pitfall.

Profits were down 43% and Pfizer needed to make cost cutting decisions.

Resulted in the loss of over 19,000 U.S. jobs in 2009 alone.

Pfizer has since outsourced the production of some basic chemical compounds to two Asian contract manufacturers.
The Commons
"In regards to outsourcing, everything is on the table." -Pfizer spokesperson.
If Universal Health Care is applied this would mean repetitive use of generic drugs within society. (affordable way of living for all)
Problem is that generic drugs are not equivalent in quality to designer drugs nor do they hold the same liability.
with.. Universal Health Care
Generic Drugs
Since 1999, generic drugs have saved the U.S. healthcare system over $1 trillion dollars.
Thats $1,000,031,000,000. Twelve zeros!
Savings from generic medications, that have entered the market since 2001, continues to grow exponentially. Currentlly a savings of $362 billions dollars.
In 2010 Medicaid and Medicare paid out, on average, $200 for a monthly brand name prescription compared to $20 for a generic version of the same drug.
It is in the commons that everyone should have the full chance to live a healthy life. Who has the right to attain you to that?
In relations to the commons, all healthcare should be attainable to everyone.
Meaning Universal Health Care in the U.S.

For patients, co-payments dropped, on average, from $23.65, for a brand name prescription, to $6.06 for its generic version.
Generic drugs are responsible for the overall savings in healthcare from the consumer to the state and federal healthcare agencies.
Economic Costs
Open source drugs
With no room for profit, healthcare costs would drop significantly.
Main reason for brand-name, generic drug costs is in the R&D/Marketing of new drugs.
In an ideal environment, the price of open source drugs would be limited to the cost of manufacture.
Cut health care cost of generic drugs by 50%+ while exponentially increasing total healthcare savings 200%.
The impact of open-source drugs on society is unknown. If they should ever rise in popularity, how would this affect generic and brand-name drug manufacturers?
It would be easy to assume that open-source drugs would put big pharmaceutical companies out of business. Thus, cutting more U.S. jobs resulting in diminished efficacy from overseas contractors. It's a slippery slope.

However, I believe very little would change as main pharmaceutical companies would pursue R&D in drugs that aren't a priority to open-source contributors and vice-versa.
Health Maintenance Organization's
Aetna, Humana, Blue Cross and Blue Shield...
Offers lower cost healthcare by restricting choices and pushing patients to lower-cost primary care.
HMO's boost profits by limiting prescription drugs to single-choice alternativess; often generic.
For example, you pay $150/mo for health insurance. You have a condition that can be treated with prescription drugs X ($7), Y($10), Z($20). The HMO stands to lose less money by restricting you to drug X($7) when drug Y could be more affective.
Prodcution Costs
Generic Drugs
Cost to produce generic drugs is less.
Only need manufacture and market.
Do not need to conduct tests on safety/efficacy.
Generic Plavix can be made for $0.03 cents.
30 day prescription may only cost $10-15
Questions
Should companies be able to monopolize on patents while low-income consumers aren't able to access the alternative, low-cost generic version for 20 years?
In the case of Karen Bartlett, do you believe the company had an ethical responsibility to pay Ms. Bartlett for her injuries?
Should the duration of patents be shorter or longer?
How can open source drugs be regulated more without compromising innovative medicines?
Why should we worry about intellectual property protection?
How has generic/brand names drugs affected you, are they the same or different... why?
Full transcript