Sunday, October 2, 2011

Contrived Shortages of Drugs and Political Pressure by Big Pharma

We are being told that hospitals are running out of drugs used in everything from cancer to surgery, anesthesia and intravenous feeding, according to the Food and Drug Administration. This year, approximately 180 drugs have been in short supply. According to the American Hospital Association, virtually all U.S. hospitals say they've been affected by the shortages that have reached a crisis situation resulting in delayed care for patients. Henri R. Manasse Jr., CEO of the American Society of Health-System Pharmacists in Bethesda, MD stated that drug shortages are a serious national health care crisis with very real consequences for patients with doctors and hospitals are postponing surgery or making do with costlier and less effective substitutes.

Drug makers claim that they’re doing everything they can to relieve the shortages – but are they really???? Suddenly we have a shortage of critical pharmaceutical drugs but perhaps this really is a ploy to get political support for the push for legislation that will help maximize profits for the drug companies. Whenever the drug manufacturers have a need to put pressure on Congress to pass legislation favorable to the pharmaceutical industry, we suddenly have problems with drug shortages.

The Pharmaceutical Industry is Very Profitable

The economic picture for other industries in the U.S.A. may be bleak but in the US the pharmaceutical industry has proven to be the most profitable of all businesses. In the annual Fortune 500 survey, the pharmaceutical industry topped the list of the most profitable industries with a return of 17% of revenue. Global spending on prescription drugs topped $643 billion in 2006. The United States accounts for half of the global market in pharmaceutical products. Pfizer had annual sales of one of their cholesterol medications Lipitor of $12.9 billion. Pfizer had total revenues of $67,809 million and net income of $19,337 million in 2006. Merck & Co. had total revenues of $45,987 million and Johnson and Johnson had total revenues of $37,020 million. The future of the pharmaceutical industry is expected to be rosy with increasing profits in most sectors despite loss of some patients. One of the most profitable of the pharmaceutical products is the rapidly expanding market for psychotropic or psychiatric drugs – especially non-typical SSRI’s.

The phrase Big Pharma is often used to refer to companies with revenue in excess of $3 billion, and/or research and development expenditure in excess of $500 million. The primary trade group for the pharmaceutical industry spent $4.7 million in the second quarter of this year lobbying the federal government on prices that federal health programs pay for prescription medicines and on other issues including patents, drug shortages and reimportation of drugs, according to a quarterly disclosure report.

The Pharmaceutical Research and Manufacturers of America, known as PhRMA, lobbied on implementation of aspects of the 2010 health care overhaul, including prices and rebates for drugs bought through the Medicare program. The lobbyists pushed for legislation that would bar marketing of authorized generic drugs, legislation which allow makers of brand-name drugs to partner with a generic company to retain more revenue after their patents expire. PhRMA also lobbied on the 2012 federal budget and 2011 appropriations for the Food and Drug Administration, National Institutes of Health and other agencies and departments.

According to the Center for Public Integrity the pharmaceutical and health products industry has spent more than $800 million in federal lobbying and campaign donations at both federal and state levels in the past seven years. Its lobbying operation, on which it reports spending more than $675 million, is the biggest in the nation. Only the insurance industry has spent more money to sway public policy. The claim that the profits of the industry are put back into to research and development does bear scrutiny because in reality more than a third of pharmaceutical companies' resources go into promotion and marketing.

But we really cannot assume that the pharmaceutical industry has the best interests of the American public or patients when putting pressure on the US Congress. Are these drug shortages real or are they created in order to sway public opinion and put pressure on the US Congress to win political battles over legislation? These companies claim that it is expensive to bring drugs to market and that they need greater profits in order to spend money on research and development. But let’s look what they really spend their money on. Reports estimate that the industry spent between $30 billion to $60 billion on marketing in 2004.

Let’s look at the history of the pharmaceutical industry and whether it’s lobbying efforts are actually in the public interest. Let’s see if the claims of drug shortages and inadequate profits on drugs are really true. According to PublicIntegrity.org, more than a third of pharmaceutical companies' resources go into promotion and marketing. In 2003, the pharmaceutical industry spent nearly $116 million to lobby the government. That year the Congress passed, and President George W. Bush signed, the Medicare Modernization Act of 2003, which created a taxpayer-funded prescription drug benefit for senior citizens. Pfizer $16.90 billion in marketing and only $7.68 billion in research & development. The trade group PhRMA estimates its members spent a total of only $39 billion on R&D in 2004.

The Texas Medication Algorithm Project (TMAP)

The controversial New Freedom Commission on Mental Health was established by the 43rd U.S.A. president, George W. Bush, in April, 2002. The Commission was established to conduct a comprehensive study of the U.S.A. mental health service delivery system and make recommendations based on its findings. The New Freedom Commission on Mental Health recommended increased use of pharmaceutical interventions despite the Food and Drug Administration (FDA) response, with regulatory steps, to reports of increased rates of suicide, especially during the first months of drug use. Allan Jones was the former investigator in the Commonwealth of Pennsylvania Office of Inspector General (OIG), Bureau of Special Investigations. As a human rights defender and medical whistleblower, Alan Jones, investigated for the Office of Inspector General of FDA. He delivered a scathing report on the fraudulent behavior of the pharmaceutical industry and its political control over both legislation and regulatory functions. Civil liberties groups also became vocal opponents of the Texas Medication Algorithm Project (TMAP). The TMAP was described as a thinly veiled proxy for the pharmaceutical industry, which pursued profits by recommending more psychotropic medication interventions. TMAP had been created in 1995 while President Bush was governor of Texas. It formed as an alliance of individuals from the University of Texas, the pharmaceutical industry, the mental health and the corrections systems of Texas.

Through TMAP, critics contend, the drug industry has methodically influenced decision-making of elected and appointed public officials. The strategy increased access to citizens in prisons and state psychiatric hospitals. Some opponents of TMAP believe its objectives are to foster chemical-mediated behavior control of American citizens. The Commission used TMAP as a blueprint and began to recommend screening of American adults for untreated mental illnesses and children for emotional disturbances. This targeted more vulnerable populations who could be coerced to use the newer psychotropic medications. Some of these drugs were still in clinical trials or were to be prescribed as extra-label use (i.e., not specifically authorized but tolerated). As a U.S.A. regulatory agency, however, the FDA initiated regulatory actions to address reports of increased suicide rates. One of these actions was to require a “black box” warning label for the new anti-depressants that warned of increased risk for violent tendencies, including suicide, caused by these medications.


The pharmaceutical industry works to change our public policy and to maximize profits for themselves. So when suddenly critical drugs are in short supply, we need to ask as informed voting citizens, is this for real?? Or is it a contrived drug shortage meant to put pressure on the US Congress and to divert even more federal funding to pharmaceutical research and to pay unnecessarily high prices for pharmaceutical drugs.

References and Citations:

1. Forum piece by Susan Kennedy, "Column: Drug shortage: What can I do?"
http://content.usatoday.com/topics/topic/American+Hospital+Association

2, "Why We Pay So Much," TIME magazine, Feb. 2, 2004

3, Top 50 Pharmaceutical Companies Charts & Lists, Med Ad News, September 2007, http://www.pharmalive.com/magazines/medad/?date=09%2F2007

4. The controversial New Freedom Commission on Mental Health was established by U.S. President George W. Bush in April 2002 to conduct a comprehensive study of the U.S. mental health service delivery system and make recommendations based on its findings. The commission, using the Texas Medication Algorithm Project (TMAP) as a blueprint, subsequently recommended screening of American adults for possible mental illnesses, and children for emotional disturbances, thereby identifying those with suspected disabilities who could then be provided the newer psychoactive drugs. The strategy behind the commission was developed by the pharmaceutical industry, advancing the theory that the primary purpose of the commission was to recommend implementation of TMAP based algorithms on a nationwide basis. TMAP, which advises the use of newer, more expensive psychiatric medications based on a protocol developed by pharmaceutical industry consultants at the University of Texas. The goal was to help pharmaceutical companies to get human subjects for clinical trials and access to citizens locked in prisons and state and private psychiatric hospitals and to get these clinical trials paid for by Medicaid.

5, New Freedom Commission on Mental Health, Achieving the Promise: Transforming Mental Health Care in America. Final Report. DHHS Pub. No. SMA-03-3832. Rockville, MD: 2003. President Bush’s plan, Achieving the Promise: Transforming Mental Health Care in America, is available at MentalHealthCommission.gov, . www.mentalhealthcommission.gov/reports/FinalReport/FullReport.htm.

6. Allen Jones, “TMAP Critique,” January 20, 2004, PschRights.org, http://psychrights.org/Drugs/AllenJonesTMAPJanuary20.pdf.

7. Lenzer, Jeanne, “Secret US report surfaces on antidepressants in children,” British Medical Journal, Vol 329, p 307 August 7, 2004, PsychRights.org, http://psychrights.org/Research/Digest/AntiDepressants/BMJ-SecretReportSurfaces.pdf .

8. Lenzer, Jeanne, “Bush Plans To Screen Whole US Population for Mental Illness,” Jeanne Lenzer, British Medical Journal, Vol 328, pp1458, June 19, 2004, http://psychrights.org/Articles/BMJBushtoScreenUSpop.pdf .

9. Ismail, M. Asif, “Special Report: Drug Lobby Second to None, How the pharmaceutical industry gets its way in Washington,” PublicIntegrity.org, http://projects.publicintegrity.org/rx//report.aspx?aid=723&sid=200

10. Jones, Alex, “New Freedom Initiative/Mandatory Mental Health Screening of American Children Passes,” Infowars.com, November 23, 2004, One of the nation's leading medical groups, the Association of American Physicians & Surgeons (AAPS), decried a move by the U.S. Senate to join with the House in funding a federal program AAPS says will lead to mandatory psychological testing of every child in America – without the consent of parents. The New Freedom Initiative passed sans amendment, as it stood. http://www.infowars.com/articles/brave_new_world/new_freedom_paul_amendment.htm.

11. Breggin PhD, Peter, Recent regulatory changes in antidepressant labels: Implications for activation (stimulation), A Harvard-trained psychiatrist and former full-time consultant at NIMH, Dr. Breggin's private practice is in Ithaca, New York, where he treats adults, couples, and families with children. He also offers consultations in clinical psychopharmacology and often acts as a medical expert in criminal, malpractice and product liability suits. He is the author of many scientific articles and books including Medication Madness: The Role of Psychiatric Drugs in Cases of Violence, Suicide and Crime (2008). http://www.breggin.com/index.php?option=com_content&task=view&id=55&Itemid=79Breggin.com, www.Breggin.com. http://breggin.com/index.php?option=com_docman&task=cat_view&gid=65&Itemid=37.

12. Breggin, Peter, “Paxil Special Report III,” The third special report in a series providing excerpts from Dr. Breggin's 1999 product liability report in the CA case of Lacuzong v. GlaxoSmithKline, alleging that Paxil (paroxetine) caused a double murder and suicide. Ethical Human Psychology and Psychiatry 8 (2006) 255-263. www.Breggin.com.

13. Breggin, Peter, Evidence from many sources confirm SSRIs commonly cause or exacerbate a wide range of abnormal mental and behavioral conditions. International Journal of Risk & Safety in Medicine 16 (2003/2004) 31-49. www.Breggin.com.

14. Breggin, Peter, Report presented at the September 14, 2004 press conference sponsored by the Alliance for Human Research Protection (AHRP) at the FDA Public Hearing on Antidepressants and Suicide available at Breggin.com. www.Breggin.com.

15. A report Dr. Breggin presented to the FDA in August 2004 detailing the relation of suicidality and violence to antidepressants available at Breggin.com. www.Breggin.com.

16. According to PublicIntegrity.org, more than a third of pharmaceutical companies' resources go into promotion and marketing.
Company Marketing costs vs costs of Research and Development

Pfizer $16.90 billion in marketing and only $7.68 billion in research & development
Glaxo Smith Kline $12.93 billion marketing and only $5.20 billion research & dev.
Sanofi-Aventis $5.59 billion in marketing $9.26 billion in research & development
Johnson & Johnson $15.86 billion in marketing $5.20 billion in research & development
Merck $7.35 billion in marketing $4.01 billion in research & development
Novartis $8.87 billion in marketing $4.21 billion in research & development
AstraZeneca $7.84 billion in marketing $3.80 billion in research & development
Hoffman La Roche $7.24 billion in marketing $4.01 billion in research & development
Bristol-Myers Squibb $6.43 billion in marketing $2.50 billion in research & development
Wyeth $5.80 billion $2.46 billion in marketing in research & development

Abbott Labs $4.92 billion in marketing $1.70 billion in research & development

Annually, the industry spends nearly twice as much on marketing as it spends on research and development, although drug companies report neither total precisely. Various news reports estimate that the industry spent anywhere between $30 billion to $60 billion on marketing in 2004. The trade group PhRMA estimates its members spent $39 billion on R&D that year. As this information shows, the same year, 11 major companies reported spending close to $100 billion on marketing, along with administrative expenses not categorized separately. Those companies reported spending $50 billion on R&D. In 2004, Pfizer spent almost $120 million for media ads for Lipitor, the world's number-one selling prescription drug, while companies promoting erectile dysfunction treatments Viagra, Levitra and Cialis spent $425 million. Direct to consumer advertisement has also grown significantly: from $791 million in 1996 to $3.8 billion in 2004.