Can Merck’s HPV Vaccine Clinical Trial Process Be Trusted?

Testing in the Third World

JayaJan Pharmaceutical Research in India was one of the companies with which Merck had a contract to test Gardasil. Like most of the industry, Merck increasingly outsources its clinical trials to Contract Research Organizations (CROs) in areas of the world where trial subjects are plentiful, operating costs are low, and regulations lax.

Some $285 million worth of clinical trials are outsourced to CROs in India, according to biopeer.com.  These CROs are a booming $15 billion industry whose revenues are rising at 15 percent a year.

“CROs are known for their speed and efficiency; they can complete a clinical trial in two-thirds the time a drug company can, shaving months off the process and offering $120 million to $150 million in increased revenue per drug.” Sam Bidwell an executive with Quintiles a U.S.-based CRO told Nature. “Of the top 30 best-selling drugs, we’ve touched every one.”

Critics point out that CROs can come with built-in problems. Conflicts of interest can arise when CROs are paid royalties only after a drug is approved rather than being paid a set fee that is independent of how safe or effective the drug turns out to be. Problems can also arise because CROs know that favorable findings mean that research into a test drug will continue, and they may also believe that results that please the hiring corporation can lead to future contracts. “Companies know that the farther the compound moves through the research cycle, the more money they can raise,” Nature reported.

Merck spokesperson Amy Rose refused say how many trials Merck contracted to CROs or what percentage of the Gardasil subjects these contractors recruited in the Third World. She also refused to specify how, or even if, the company oversees CROs.

Many consumers assume that the FDA carefully monitors CROs. But the agency hobbled by under-funding, politicization, and dependence on industry fees has few resources to assess foreign trials and relies on drug companies.

In the case of the JayaJan Pharmaceutical Research Gardasil cervical cancer vaccine clinical trials, the FDA was forced to rely on the veracity of one of the largest pharmaceutical companies in the world, Merck & Co, Inc.

In the past, Merck & Co, who refers to itself as a global pharmaceutical research company, has allegedly falsified, suppressed, or misrepresented the results of clinical trials to make some of its products seem more safe than they really are.

Merck supports the Fast Food Nation by promoting drugs that treat ailments associated with bad eating habits. Drugs prescribed for high cholesterol, hypertension, and heart failure are among Merck’s most profitable product lines. Merck employed 59,800 people worldwide in 2007, and reported $24.2 billion in sales. In October 2008, the New York Times reported that Merck announced plans to cut 7,200 jobs, or 12 percent of its workforce. The layoffs are not in response to the financial crisis, but rather the result of falling drug and vaccine sales. As their patents expire, large pharmaceutical companies are faced with skyrocketing competition from cheap generics. The job cuts are expected to save the company up to $4.2 billion in operating costs over the next four years, though they will need to spend up to $2 billion in reorganization and severance costs.

Cost cutting did not extend to Merck’s ongoing political lobbying to secure state mandated HPV vaccination programs. If a vaccine is mandated by a State or Federal agency, a victim of an adverse vaccine event CAN NOT sue Merck directly. The injured individual or their surviving kin must go through Vaccine Court that has a set limit on damages. Totally sweet for Big Pharma who has been known to rush a product to market, and totally sucks for the citizens who trusted the governments Drug safety oversight process to protect them and their children.

According to opensecrets.com, during the 2008 election cycle, Merck & Co’s political action committee gave $572,499 to federal candidates. Fifty-one percent went to Democrats, 49 percent went to Republicans. Of course additional money was spent through PACs, Committees, and plain brown wrapper. How much money, to whom, to what apparent result, is a topic for a future Blog.

Green America has reported that Merck has repeatedly violated water pollution regulations and has fought against measures meant to improve water quality near its manufacturing facilities.  I don’t know how the FDA Honcho’s feel about Merck recent history in the “Good Corporate Citizen” department, but personally, I would be inclined to check for my ring, watch and wallet, if I ever bumped into a Merck exec prowling the halls of ant Local, State or Federal office.

PG

Author: H. Sandra Chevalier-Batik

I started the Inconvenient Woman Blog in 2007, and am the product of a long line of inconvenient women. The matriarchal line is French-Canadian, Roman Catholic, with a very feisty Irish great-grandmother thrown in for sheer bloody mindedness. I am a research analyst and author who has made her living studying technical data, and developing articles, training materials, books and web content. Tracking through statistical data, and oblique cross-references to find the relevant connections that identifies a problem, or explains a path of action, is my passion. I love clearly delineating the magic questions of knowledge: Who, What, Why, When, Where and for How Much, Paid to Whom. My life lessons: listen carefully, question with boldness, and personally verify the answers. I look at America through the appreciative eyes of an immigrant, and an amateur historian; the popular and political culture is a ceaseless fascination. I have no impressive initials after my name. I’m merely an observer and a chronicler, an inconvenient woman who asks questions, and sometimes encourages others to look at things differently.