The globalization of the pharmaceutical industry

Recently, there has been reports in the media on global outsourcing of domestic drugs overseas. With more clinical trials being conducted overseas the need for safety is hitting home. The New York times recently highlighted in their article "6,485 Overseas Clinical Trials and Counting" the investigative work from authors Donald L. Barlett and James B. Steele.   The authors article  Deadly Medicine was published in this months issue of Vanity Fair.  Barlett and Steele investigate the globalization of the pharmaceutical industry, and the U.S. Government’s failure to rein in a lethal profit machine."

Maureen Martino from Fierce Biotech had this to day about the Vanity Fair article; "Barlett and Steele clearly come into the article with an agenda, making sweeping accusations about unethical behavior, conflicts of interest and what they view as an overall corrupt clinical trial process. However, they raise important questions about how well-regulated trials can be when they are tucked into all corners of the world and involve people who have little or no medical resources and no agency ensuring they're being treated ethically. The FDA does what it can with the resources it has to monitor sites. But the overseas clinical trial industry has grown so rapidly that regulators are woefully unprepared to prevent and address potential abuse of the system."

At the blog Hooked On Ethics the blogger had a few key points on the same article.

The basic gist of the article is to say that US drugs are becoming less safe as companies increasingly resort to nations in Eastern Europe, Africa and Asia to get their clinical trials done, for reasons that have nothing to do with good science and everything to do with profits. Some highlights:

"The concept that is new to me, but reportedly well known to Pharma insiders, of "rescue countries." These are supposedly the counties that if you are having trouble finding evidence to persuade FDA to approve your company's drug, outsource your clinical trial to that country, and you can count on getting positive results that you can submit and gain approval. Examples: When the FDA approved the antibiotic Ketek, later shown to have huge safety problems, the decision was based heavily on trial results from Hungary, Morocco, Tunisia, and Turkey. This was shortly after a US trial physician from Alabama was sentenced to prison for falsifying 90 percent of her data."... continue reading

Outsourcing is when a company sends work to be done outside their company, some outsourcing is done for research , often in less-developed counties. In the 2009 publication of the New England Journal of Medicine researchers at Duke University wrote on the outsourcing of drug trials.

An excerpt ;
Pharmaceutical and device companies have embraced globalization as a core component of their business models, especially in the realm of clinical trials. This phenomenon raises important questions about the economics and ethics of clinical research and the translation of trial results to clinical practice: Who benefits from the globalization of clinical trials? What is the potential for exploitation of research subjects? Are trial results accurate and valid, and can they be extrapolated to other settings? In this article, we discuss recent trends in and underlying reasons for the globalization of clinical research, highlight important scientific and ethical concerns, and propose steps for the harmonization of international clinical research.
Ethical and Scientific Implications of the Globalization of Clinical Research (PDF).

Personally, as a consumer I am uncertain and fearful with the prospect of U.S. drug companies outsourcing overseas, especially to India and China. The subject of HCV is included in this entry rather it merits any cause for concern is debatable, but is worth evaluating. 

Merck and Vertex: Domestic Drug Manufacturing Outsourced
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In July of 2008 an announcement made by Merck's Richard Spoor stating that by 2010, Merck plans to outsource about 35 percent of the company's pharmaceutical ingredients and packaging. .. .
As for Vertex, supposedly they have hooked up with Shasun chemicals headquartered in India, as noted; Shasun pharmaceutical chemical manufacturer obtained a contract from Vertex Pharma for manufacturing telaprevir. Vertex will source the entire supply from Shasuns UK subsidiary. I can not find any validation on this contract from Vertex.
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In the below excerpt from the companies press release note that Shasun did not name the Vertex drug. The reason may have been because Vertex was going public a few days later.
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"The supply of the Hepatitis C drug to Vertex by Shasun Chemicals is set to take off earlier than anticipated. The product is set to launch in June-July next year. "Commercial supplies have already started and we are preparing for the launch this year," says Vimal Kumar, Managing Director of Shasun Chemicals, in an exclusive interview with CNBC-TV18's Udayan Mukherjee and Mitali Mukherjee."

Saftey
Can the FDA ensure the safety of drugs that are outsourced ?
Over the last two years the U.S. has had problems, as for example the contaminants in the drug heparin; "Authorities believe that the contaminant; oversulfated chondroitin sulfate, a substance that mimics heparin but costs 99 percent less, entered the drug’s supply chain in China." . Then there was the sad and unfortunate melamine milk incident in China which resulted in six deaths and the hospitalization of over 300,000 babies.

In August the online publication of Pharma Manufacturing ran a piece on the FDA improving drug safety in China, noted in the article; "The head of the U.S. Food and Drug Administration says China is improving its oversight of its exporters following a slew of scandals over bogus or substandard drugs and foods ranging from vaccines and infant formula to dog chow. FDA Commissioner Margaret Hamburg said Friday that Chinese officials she spoke with during her first visit to China since she was appointed were pursuing a "common agenda" to improve manufacturing practices and regulation of complex supply chains for the food and drug industries." 

The Profit

Again from The New England Journal of Medicine
What has led to this dramatic shift in the location of clinical trials? One explanation is that pharmaceutical and device companies can realize substantial cost savings by conducting trials in developing countries, so they are increasingly moving phase 2 and phase 3 trials to places such as India and South America.10,11 A pharmaceutical executive reported that a first-rate academic medical center in India charges approximately $1,500 to $2,000 per case report, less than one tenth the cost at a second-tier center in the United States.10 Since clinical research costs are driven by human labor, much of this cost difference is attributable to the lower salaries of physicians, nurses, and study coordinators in developing countries.12
Maybe outsourcing is profitable for pharmaceutical companies but is it safe for American consumers ?

In July written in the online issue of Economy in crisis the author Dustin Ensinger wrote;
"Once thought to be a safe-haven for American manufacturers, the U.S. pharmaceutical industry is no longer immune to the outsourcing phenomenon, which poses major risks for American consumers.
According to The New York Times, India is becoming a major destination for American pharmaceutical companies seeking to boost their bottom line. Taking their cues from other American multinational corporations, they are doing so by outsourcing their manufacturing to the Indian subcontinent.
" The article/blog entry is short and again worth looking at.

Health Care Outsourced ??
Outsourcing Health Care has led to Medical Tourism
by Craig Harrington on November 3, 2010
"According to CNNMoney.com, one company sent a husband and wife on an all-expenses-paid vacation to Panama for two weeks as part of their “travel surgery” arrangement and still ended up saving 80 percent on what would have been a $50,000 procedure in the United States.

If an employee is concerned about the medical accreditation of a center in Panama or India – where costs can be on average 80 percent lower – they could go to a developed country and still save money. Even after paying for airfare and hotels, and dealing with the exchange rate for dollars, a company can save 25 percent or more by sending employees to the United Kingdom for surgeries. " Continue Reading............

Ethics: Outsourcing to China
The worse offenders of transplant tourism are China, the Philippines, Pakistan, Egypt and Colombia. The reality is, poor people in these countries sell their livers or kidneys to patients in rich countries in need of them.

With the apparent widespread knowledge of organ trafficking in China and these other countries, I ask why are U.S. pharmaceutical companies working arm in arm with these overseas countries ? Not only should the U.S. not collaborate in development or research they should stop exporting drugs that are used in transplant surgery.

Organ Trafficking
On Dec 29th ABC news published an online graphic verbal description of organ trafficking in India;
Organ traffickers luring Nepal's poorest to India
Experts fear organ traffickers are targeting poor people in Nepalese towns in an effort to lure them over the border to neighbouring India where transplant laws are weaker. Sociologist Ganesh Gurung has conducted research into organ trafficking in the Nepalese district of Kavre, where several poor villages are located.He says traffickers are promising desperate farmers money or lying to them in order to bring them over the border to India to have a kidney removed.
Under Nepalese law, kidney transplants are allowed only if the organ is donated by a blood relative or spouse. But India's laws are more lax, allowing a non-relative to donate an organ "out of affection", subject to the approval of a medical committee - a checking process which can often be circumvented.
Continue Reading..............

Today CBS news ran this story Jan. 11, 2011

Turk Detained in Kosovo Organ Trafficking Probe
Doctor Is Suspected of Carrying Out Dozens of Operations as Part of Alleged International Organ Trafficking Ring
A European Union prosecutor has named seven people as suspects in an international organ trafficking network, according to the indictment obtained Thursday by The Associated Press.
"These victims were recruited in other countries, then transported and received at Pristina Airport through the false promise of payments for the removal of their kidneys," Ratel said in the indictment. He said victims were promised up to $20,000 (14,500 euros) while recipients were required to pay between 80,000 and 100,000 euros ($110,000-137,000).

China: First conviction for human organ trafficking in Beijing
September 16, 2010
Under Chinese law, organ trafficking is not a crime per se; thus, traffickers were convicted for “illegal business operation”. So far, the authorities have tolerated the practice or even used death row prisoners’ organs for transplant.
Human rights groups have accused Chinese authorities of allowing trafficking of organs taken from prisoners, for instance, members of Falun Gong. Some go so far as to charge Beijing of keeping thousands of death row prisoners alive until their organs are needed.

Falun Gong Targeted
Dr. Eric J. Goldberg said that after reading all the literature written by David Matas and David Kilgour, he determined that the allegations are valid. “Why would Falun Gong be targets? According to Matas and Kilgour, they have been declared ‘enemies of the state’ and are non-citizens without rights, thus they can be used for any purpose the state deems economically appropriate. There are 70 to 100 million Falun Gong and tens of thousands are interned throughout China in labor camps and prisons. They are given no legitimate trial or legal representation. They are the only group that is given regular physical exams and are tissue typed while in custody.”Speaking of what happens after the harvesting procedure is completed, he said, “As horrific as it sounds, the anesthesiologist stops the ventilator and the victim dies. The bodies are then taken to crematoriums, according to interviews that Kilgour and Matas have chronicled.”

Dr. Goldberg discussed and answered questions on Dec. 22 on the issues of organ harvesting and transplantation in China with Dr. Dana Churchill, the Southern California spokesperson for Doctors Against Forced Organ Harvesting (DAFOH). It is a non-profit founded by medical doctors to inform the medical community and the public with findings of unethical and illegal organ harvesting. The non-profit was the organizer of the discussion and press-conference.

David Matas and David Kilgour in 2010 were Nominated for Nobel Peace Prize.

Related Link: Bloody Harvest: Stealing Organs For Profit

On this blog you can view a video and read more about the members of Falun Gong :Organ Harvesting In China

Today published at The Jakarta Globe is one woman's story on her plight to find safety and peace.
After Fleeing China, Falun Gong Practitioners Find Safety in Indonesia, Though Worries and Wishes Remain


Roche Gets “Shame” Awards in Davos for Transplant Drug Trials in China

 

In The News
Ligand pushes into China with liver drugs deal
By Keith Darcé
Originally published January 6, 2011 at 10:30 a.m., updated January 6, 2011 at 3:38 p.m.In its first move into the potentially lucrative Chinese market, Ligand Pharmaceuticals said Thursday that it partnered with the U.S. affiliate of a Hong Kong drug company to develop and market two experimental liver disease drugs in China.

SciClone Junks Experimental Drug; Looks to China Expansion
By Brett Chase Dec 16, 2010 3:00 pm
An experimental drug for chronic hepatitis C failed in a study but investors should note the company's potential growth in China. Shares of SciClone dropped as much as 9% in morning trading after the company said its chronic hepatitis C drug didn’t meet targets in the middle stages of testing. The drug, SCV-07, is being scrapped. What matters most is growth in China, a market coveted by a number of drug companies big and small.



If you have the time I urge you to read the Vanity Fair article