Do Drug Firm Bribery Charges Implicate the U.S. FDA?
How can anyone have implicit faith in the science and products produced by BIG Pharma when The Wall Street Journal on October 5, 2010 featured the article “Drug Firms Face Bribery Probe” by Michael Rothfeld?
That question automatically should be followed with, “Will those charges also implicate the U.S. FDA?” Not knowing all the facts, but being of a suspicious nature, I’d say anything is possible given the long-term revolving door policy that seems to exist within government agencies, Big Pharma, and the chemical industry. This is where the U.S. Congress, in my opinion, has been—and continues to be—remiss in its oversight duties.
If one studies pharmaceutical demographics, as I have for years, one readily realizes that starting in the 1980s, Big Pharma companies began their push and drive to manage healthcare via their products by using what many feel are scare tactics in media advertising and unreliable science—something that the FDA apparently condones and even seems to parrot.
A probable ‘backdoor’ statistic supporting that contention is this: Adverse drug reaction (ADR) reports between 1995 and 2005 and those between 1985 and 1995. Adverse drug reaction reports made to the FDA almost tripled between those two decades! They went from 156,000 during 1985-1995 to 460,000 in 1995-2005 according to FDA reports, and as cited in the exceptional book recently published by Columbia University Press, The Risks of Prescription Drugs.
Not only that, but ADRs seem to be rising at a rate of 15 percent per year. Even more disturbing is the remark by former FDA Commissioner [November 8, 1990 to February 28, 1997], David A. Kessler, that only one percent of serious ADRs are reported to the FDA.  If that’s the case, then we can understand why so many older folks are ‘zombies’ and children are suffering with all types of medical syndromes not reported in the literature until the last twenty to thirty years? Accordingly then, a rough guesstimate would approximate that one-sixth of the United States population could be experiencing adverse drug reactions, which inadvertently affect the costs of healthcare, Medicare, Medicaid, and personal health plans.
According to EHow online, The Medicare Board of Trustees estimates that Part D program costs, $49.3 billion in 2008, will increase from $66.2 billion in 2010 to $140.9 billion in 2018. (http://www.ehow.com/facts_6798510…)
How can such a damaging ‘legal drug culture’ with its ‘nefarious’ ADRs flourish right under law authorities’ noses? Probably because of the pharmaceutical industry’s rush to get drugs approved “under the wire” and this—something you may find unsettling:
The more recent speed-up in FDA review times negotiated by the pharmaceutical industry in return for subsidizing the FDA’s drug approval process has resulted in the prescription of many newer drugs that subsequently prove dangerous enough to end up requiring warnings, restrictions, or removal from the market. 
Parsing the above “…in return for subsidizing the FDA’s drug approval process…” may mean a financial funding for services at FDA. If that’s the case, I wonder how kindly members of Congress take to that? Could that mean a quid pro quo arrangement exists within an agency that healthcare consumers and taxpayers think is working to protect them, not facilitate Big Pharma?
The Wall Street Journal article contends that federal investigators are looking at Big Pharma members Merck & Co., AstraZeneca, Bristol-Myers-Squibb Co., and GlaxoSmithKline for possible violations against the 1977 Foreign Corrupt Practices Act.
If that’s the case, what role, if any, did these corporations play in the 2009 Swine flu vaccine debacle wherein allegations were made by member states of the European Union and other countries that they were ‘strong armed’ into placing orders for vaccines. The only country that did not buy into the scheme was Poland, whose health minister apparently saw through the moneymaking scheme and apparent ‘shake down’. Could that be classified as bribes to government officials? How about the United Nations and the World Health Organization?
Federal investigations are targeting Big Pharma’s ‘business tactics’ in Brazil, China, Germany, Italy, Poland, Russia, and Saudi Arabia, according to The Wall Street Journal. Here are the possible violations that those companies could face:
- Bribing government-employed doctors to purchase drugs;
- Paying company sales agents commissions that are passed along to government doctors;
- Paying hospital committees to approve drug purchases;
- Paying regulators to win drug approvals. 
Incidentally, foreign pharmaceutical sales in 2009 were reported to be $103.4 Billion, or a third of all sales.  To understand where Big Pharma is heading, check out the Pharmaceutical Industry Profile 2009 PhRMA report at (http://www.phrma.org/files/attachments/PhRMA…).
But where does that leave us with regard to flu vaccine information put forth by Big Pharma and vaccine makers regarding 2009 H1N1 Swine/Mexican flu vaccine safety and efficacy studies—if any—that were used to sell that supposedly two-week-tested vaccine? That’s even more important than bribery charges, since it’s a known fact that pharmaceutical makers ‘fudge’ information and publish in-house produced “peer review studies.” Or, shouldn’t we ask that question?
The 2010 flu season is rapidly approaching in the Northern Hemisphere. Will there be a rush by governments to stockpile flu vaccines this year despite a growing concern on the part of the public about vaccines—and the flu vaccine in particular—especially in view of last year’s unfortunate—and perhaps planned—debacle that backfired? Or, will Big Pharma continue its ‘steamroller’ tactics to make vaccines the mandated ‘choice’ in pharmaceuticals?
- Light, Ed., Donald W. The Risk of Prescription Drugs (New York: Columbia University Press, 2010), pp.2-3
- Ibid, pp.1-2
- Rothfeld, Michael. Drug Firms Face Bribery Charges, The Wall Street Journal accessed Oct. 16, 2010 http://online.wsj.com/article/SB10001424052748704847104575532091781199092.html