Tag Archives: vaccines

How the Pharmaceutical Industry became into existence?

The Birth of the Pharmaceutical Industry can be traced back to 1850 – 1875 where the first “authentic” drug was developed by extracting agents from plants.

In those years, there were also developed the microbial theory of disease, medicines and homoeopathy patent and there heavy use of powerful purgatives and cathartics medicines.

By 1875, the Drug Development becomes a science and the first synthetic drug was introduced. By 1900, vaccines and antitoxins form the basis of the new pharmaceutical industry.

From 1900 to 1925, began what is now known as the pharmaceutical century. The U.S. Pure Food and Drugs Act was passed (known today as the FDA) and the development of hormonal and chemotherapy was introduced.

After 1925, it began what is known today as the Antibiotic and Regulatory Era. Vitamins, antimalarials, anticarcinogenic compounds and anti-infectives discoveries were made. The FDA gains independence as a regulatory agency and is given compliance responsibility.

From 1950 thru 1975, a new generation of the drug became apparent. Vaccines for polio became mandatory, oral contraceptives appears on the market and cardiovascular therapies.

Also, an amendment to the Federal Food Drug and Cosmetic Act of 1938 Act was signed by President Kennedy to ensure that consumers will not be the victims of unsafe and ineffective medications. Additional information about this Act can be read here: Kefauver-Harris Amendments

The Globalization of the Pharmaceuticals industry started from 1975 thru 2000. New drugs therapies, new antiviral drugs, and the development of new drugs by biotechnology companies were in global high demand.

By 2000, over 2.8 million people participated in over 50,000 clinical trials and more research and development funding was increased.

R&D Expenditures by Body System

R&D Expenditures

Cost (Billions) Body System
7.0 Central Nervous System
6.0 Cancer, endocrine and metabolic
4.5 Cardiovascular
3.5 Infectious Disease
2.5 Biological and vaccines
5.3 Other

Current Trends in the Industry since the late 2000s

Biotechnology Medicines
Drug Intervention Targets
Vaccines

 

Role of Generic Drugs
Generic drugs account for over 47% of prescription drugs in the market in which 43 major prescription drugs come off patent by 2005.

What does this mean for pharmaceutical drugs?
Between 40% – 60% of sales are lost to the generic brand within the two years of coming off patent.

Factors that will impact the R&D future:

  • There has been over 40 mergers and acquisitions since 1985
    • Sanofi and Synthelabo
    • Zeneca and Astra
    • Monsanto and Pharmacia
    • Roche and Genentech
  • Employment grew at a 3% rate per year

Total Drug Development Time (Years)

Summary:
On average, it takes at least ten years for a new medicine to complete the journey from initial discovery to the marketplace, with clinical trials alone taking six to seven years on average. The average cost to research and develop each successful drug is estimated to be $2.6 billion.

Pharmaceutical Regulation

In 1902, about 10 children die after receiving a vaccine shot. The BIOLOGICS CONTROL ACT was passed to ensure purity and safety of serums, vaccines and similar products used to prevent or treat diseases in humans.

In 1906, “The Great American Fraud” reveals patent medicines laced with addictive drugs, toxic additive and alcohol.

In 1912, Public outcry over the sales of “snake venom” and other wonder cures.  The SHERLEY AMEND was passed to prohibit labelling medicines with false therapeutic claims intended to defraud the purchaser.

In 1927, the government forms a separate law enforcement agency called the Food, Drug and Insecticide Agency.

In 1937, about 107 people, including many children die after drinking a syrup called Elixir of Sulfanilamide. Due to safety concerns, The Federal, Food, Drug and Cosmetic Act (1938) was passed as the first attempt to regulate cosmetics and medical devices.

In 1962, the sleeping pill “Thalidomide“, developed what is known today as Grunenthal Pharmaceutical in Germany, resulted in thousands of birth defects in Western Europe. The KEFAUVER-HARRIS Drug Amend was passed to ensure drug efficacy and greater drug safety.

In 1983, the ORPHAN DRUG Act was passed enabling the FDA to promote research and marketing of drugs needed for treatment of rare diseases. This year there as an outbreak of HIV / AIDS cases.

In 1988, The FOOD and DRUG ADMINISTRATION ACT were established as the FDA under the Department of Health and Human Services.

In 1992, the pharmaceutical industry complained that life-saving drugs were being reviewed too slowly by the FDA. The PRESCRIPTION DRUG USER FEE ACT (PDUFA) is made into law.

Source:

Image: Courtesy of Google image

FDA website

Private information for college researched in the 2000s.

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Eliminating Informed Consent on Human Experimentation with Vaccines and Drugs

The 21st Century Cure Act would demand that the Food and Drug Administration (FDA) add an exemption from informed Consent requirements for those clinical trials that pose no more than minimal risks and the appropriate safeguards protecting the right, safety and welfare of subjects.

Informed Consent Waiver

The above can be found in section 3024 – Informed Consent Waiver or Alterations for Clinical Investigations.

So what they are saying now they don’t have to obtain informed consents to test vaccinations or drugs on humans beings if it has been determined that the proposed pose no more than minimal risks.

Let’s review the Exemption  for Devices for Investigational Use

(g)(1) The purpose of this section to encourage to the extent consistent with the protection of public health and safety and ethical standards, the discovery and development of useful devices intended for human use and to that end to maintain optimum freedom for scientific investigators in their pursuit of that purpose.

In other words, you can get an exemption for certain conditions.

Question: if you don’t have informed consent in clinical trials experimentation on people, then how does anyone knows you are not part of an experiment?

If sponsors and clinical researchers not longer has to tell you that you are part of it or get your consent to informed you what they are doing? That may sound a little crazy.

Further source of research:

The 21st Century Cures Act Implications

Say Goodbye to Vaccine Safety Science by Barbara Loe Fisher

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