New drug regulator asks Congress for more power;outsourcing drugs overseas

New drug regulator asks Congress for more power

By Anna Yukhananov

In a June report outlining its new global strategy, the FDA said about half of all medical devices and 40 percent of pharmaceuticals are made abroad, with some 80 percent of the active ingredients in U.S. drugs also manufactured overseas.

WASHINGTON Fri Jul 29, 2011 5:18pm EDT

WASHINGTON (Reuters) - Drug companies should take more responsibility for the safety of ingredients sourced overseas, and Congress should make them if they do not, according to the new U.S. drug regulator for import safety.

The Food and Drug Administration should also have the power to stop medicines at the border if their manufacturers refused FDA inspections, and the power to order mandatory recalls of unsafe products, said Deborah Autor, the agency's newly appointed deputy commissioner.

"People are shocked when they learn that we do not have mandatory recalls (of drugs)," Autor told Reuters in her first interview since she was named head of global compliance earlier this month.

Autor has been making these arguments for at least three years, ever since a contaminant-laced blood thinner, heparin, made its way to the United States from China killing 81 people and sparking lengthy congressional hearings about the FDA's authority.

At the time, Autor was director of the FDA's compliance office, making her directly responsible for unsafe or ineffective drugs.

Since the heparin scandal, she has also overseen the response to a series of massive over-the-counter medicine recalls from healthcare giant Johnson & Johnson and garnered a public service award nomination for cracking down on counterfeit or unapproved prescription medication.

In the newly created role of deputy commissioner for global regulatory operations and policy, Autor will be responsible for similar issues of consumer safety, but with a much larger scope, working to ensure drugs, food and clinical trials from abroad adhere to standards comparable to those in the United States.

RESPONDING TO GLOBALIZED WORLD

Her new office, now a major FDA center alongside medical products and food, is part of the agency's big push in recent years to transform itself into a globally focused regulator that can address the growing amount of imported food and drug ingredients that are consumed in the United States.

In a June report outlining its new global strategy, the FDA said about half of all medical devices and 40 percent of pharmaceuticals are made abroad, with some 80 percent of the active ingredients in U.S. drugs also manufactured overseas.

Between 2007 and 2015, it is estimated that imports of FDA-regulated products will triple, while the agency's inspections budget is unlikely to keep up.

Even at current rates, it would take an estimated nine years for FDA to inspect every high-priority pharmaceutical facility just once, it said.

While the FDA asked Washington for new authority in 2008, the overhaul of U.S. food safety which passed Congress in 2010 did not include provisions about drug safety.

The Food Safety Modernization Act gave the FDA power to order mandatory recalls of food, but drug statutes remained largely the same as they were in 1938.

This time around, Congressional action may be more likely. At a Senate hearing on Thursday, Tom Harkin, the chairman of the influential Health, Education, Labor and Pensions Committee, said one of his policy priorities was "helping to ensure the integrity of our global pharmaceutical supply chain." He will hold hearings on the issue in the fall.

The Committee is likely to give the FDA stronger authority over drugs as part of a broader bill to renew FDA industry fees, which expire next year.

"We've talked about this quite a bit publicly," Autor said. "So I'm glad to see Congress picking it up."

TRUSTED PARTNERS

Autor started her public health career as a trial attorney at the Department of Justice, litigating civil and criminal cases on behalf of the FDA, before joining the agency's office of compliance in 2002.

Her top priority when she begins her new job as early as next week is to build more partnerships with global regulatory authorities, especially in Europe, Australia and Canada.

Recognizing that it is impossible for a single country to inspect the world's drug supply, Autor said she will work with counterparts to share information on inspections and make sure medical product facilities and clinical trials run according to "science-based standards."

Like the 60-year-old model for international air traffic control, the FDA wants to create a system of mutually recognized safety regulations.

"This model necessitates mutual reliance, even with countries that have different standards," Autor said. "To me, it matters whether we are comfortable with the outcomes of their systems.

"If I were in Europe, I'd feel comfortable taking European drugs," she said.

Maybe less so drugs from China or India, the major countries for drug manufacturing. Together, in 2007 they housed nearly 70 percent of the world's manufacturing sites for active drug ingredients, up from 49 percent in 2004, according to a report by Pew Health Group, "After Heparin."

Besides heparin, Chinese manufacturers have been linked to a series of consumer product recalls ranging from contaminated pet food to excessive lead in paint that saw millions of toys swept from stores.

"The level of advancement of a local regulatory authority can affect the level of risk associated with a locality's products," Autor said. "But I think bad things can happen anywhere in the world, including here in the U.S.

"We need to look at every link in the supply chain and consider every risk."

(Reporting by Anna Yukhananov; editing by Michele Gershberg and Matthew Lewis)

From Pharmalot;Congress Widens Probe Into The Heparin Scandal

For those of you who frequent this blog you may have noticed how habit-forming the site Pharmalot is.
Today Mr. Ed Silverman has written two articles which you may want to check out. One covers the Heparin scandal "Congress Widens Probe Into The Heparin Scandal" and the other is related to what doctors think of the pharmaceutical industry "What Docs Think Of Pharma & Where They Get Info."

On the Heparin scandal the author writes;

Three years after the FDA linked the Heparin scandal to contaminated supplies from China, the House Energy and Commerce Committee is expanding a probe into the episode and wrote 10 drugmakers, manufacturer reps and ingredients suppliers for documents, because the agency has indicated they have info about the Chinese heparin industry and supply chains.

The move comes after the committee has twice lashed out at the FDA for failing to find those responsible for the scandal, which was linked to 81 deaths in 2007 and 2008 and traced to heparin sold by Baxter International (back story). The fatalities provoked harsh criticism of the FDA for not conducting greater oversight of foreign facilities - particularly those in China that make medicines or supply active pharmaceutical ingredients. Baxter recalled its heparin, which contained an active pharmaceutical ingredient derived from pig intestines (see photo) from hogs in rural China.

Read more at http://www.pharmalot.com/

Overseas Clinical Trials; Big Pharma's global guinea pigs-Special Report From Reuters

By Ben Hirschler

Special report: Big Pharma's global guinea pigs

LONDON | Fri May 6, 2011 11:14am EDT

LONDON (Reuters) -

The Polish port city of Gdansk is famous for its shipyards. Hungary's fifth largest city, Pecs, is known for its ancient architecture and brewery. Neither is particularly renowned for medicine. Yet when AstraZeneca Plc tested its big new drug hope Brilinta on heart attack patients in a major clinical study, it was hospitals in these places that enrolled some of the highest number of patients anywhere in the world.In fact, Poland and Hungary together accounted for 21 percent of all subjects studied in the pivotal 18,000-patient trial -- more than double the United States and Canada combined.
A few years ago that would have been unthinkable. Major drug companies, with an eye on the commercial promise of the world's largest and most profitable market, would have run half their tests on a major cardiovascular medicine like this in U.S. hospitals under the supervision of U.S. doctors.

Today, the clinical trials business has gone global as drugmakers seek cheaper venues for studies and cast their net further afield for big pools of "treatment-naive" patients who are not already taking other drugs that could make them unsuitable subjects for testing new ones. And it is not only the practicalities of running big clinical trials as efficiently and cheaply as possible that is driving the change. The drug industry is also paying a lot more attention these days to the promise of emerging markets, whose healthcare authorities, just like those in the United States and Western Europe, are keen to see cutting-edge science conducted in their backyards.

"The motivation to involve lots of patients is very high in Eastern European countries and also in Asia," says Dr. Ivan Horvath, head of interventional cardiology at the University of Pecs. "There are three factors driving this. Our patients get access to a new drug, which is free during the trial. It is also very important for scientific reasons. And we get paid."

The increasing reliance on clinical trials in Eastern Europe, Asia and Latin America raises serious questions. Is the quality of the data as reliable as that from a top U.S. medical center? Is it safe to extrapolate common clinical effects from studying patients with different lifestyles and genetic profiles? And are ethical standards in testing new drugs properly upheld in poorer countries? After all, there is an unhappy history of exploitation of the disadvantaged in trials, as highlighted by a shocking U.S. study in the 1940s which saw prisoners and the mentally ill deliberately infected with syphilis in Guatemala.

Given the sea change, it's perhaps no surprise that the rush to globalize clinical studies is starting to cause some headaches.

SOMEWHERE ELSE
In the United States, the widespread "off-shoring" of research was highlighted in a report last year by the inspector general of the Department of Health and Human Services, which revealed just how reliant the country has become on foreign testing. In 2008, a total of 78 percent of all subjects participating in trials to support drug applications submitted to the Food and Drug Administration (FDA) were enrolled at foreign sites -- and as more experimental medicines move through the pipeline the numbers are set to increase further.

In Europe, the picture is similar, with 61 percent of patients in pivotal trials submitted to the European Medicines Agency (EMA) between 2005 and 2009 coming from third countries. A further 11 percent of patients were enrolled in studies in Eastern European countries that are now members of the European Union. The number of Polish patients involved in such trials rose fivefold over the period, while Hungary was up 3-1/2 times.

"Today, wherever you stand in the world, the larger part of the data from clinical trials comes from somewhere else, so you have to have confidence in the framework in which those trials were done," says Fergus Sweeney, head of compliance and inspections at the London-based EMA, Europe's equivalent of the FDA.

Sweeney -- an Irish pharmacologist who has been working on inspections at the agency since 1999 and who chooses his words carefully -- spends an increasing amount of time grappling with the problem of foreign trials. But he admits the number of research sites actually inspected by EMA or FDA officials remains "tiny."
Drug companies are also finding that conducting clinical trials in dozens of countries at once is a tricky business and results can be unpredictable. Just ask AstraZeneca.

Its drug Brilinta -- a rival to Sanofi-Aventis SA and Bristol-Myers Squibb Co's $9 billion-a-year seller Plavix, the world's second biggest-selling prescription medicine -- is potentially huge.
Yet while Brilinta has already been approved in more than 30 countries, including those in the European Union, it has been delayed in the United States -- the one market that will ultimately make or break it commercially. The reason? While the big trial known as PLATO found Brilinta was clearly superior to Plavix at preventing cardiovascular deaths globally, people in North America actually seemed to do worse on the new drug.

Why is unclear. One theory is that U.S. heart patients get given more aspirin alongside other medicines and this may somehow interfere with Brilinta's effectiveness. But it might just be play of chance, since the North American sub-group - which accounted for only 9.7 percent of patients -- was too small to draw any statistically sound conclusions.

Whatever the explanation, the discrepancy has left the new drug hanging in the balance. Some industry analysts think the FDA may demand further evidence before approving it in the United States, despite an advisory panel vote in its favor last year. These days the FDA has little appetite for sticking its neck out and officials will think long and hard before approving a drug that might not work for Americans. The watchdog has been slammed in recent years for failing to prevent a string of drug safety scandals, including heart problems linked to Merck & Co Inc's now withdrawn painkiller Vioxx and GlaxoSmithKline Plc's diabetes pill Avandia, as well as deaths from contaminated Chinese supplies of blood thinner heparin.
The U.S. agency is due to give its verdict on Brilinta by July 20 -- but the ripples from this study have already spread widely. According to an analysis of the situation by Dr. Magnus Ohman and Dr. Matthew Roe of Duke University Medical Center, the PLATO results "should serve as a warning to all stakeholders in global cardiovascular research that balanced enrollment around the world in pivotal trials should be the goal for any future drug development program."

AstraZeneca says it is confident in the conduct and results of the trial. Yet the study is now a red-hot topic for pharmaceutical investors and it has also got a lot of doctors talking.

THROWING IN THE TOWEL
April's annual meeting of the American College of Cardiology (ACC) in New Orleans was the usual frenetic mix of world-class science, networking and lobbying by the $850 billion-a-year pharmaceutical industry, seeking to promote its wares to key opinion leaders. The commercial razzmatazz of the convention centre's giant trade stands, advertising big brand drugs and medical devices, painted a bright picture for medical science.

Under the surface, however, a growing number of doctors are worried about the tectonic changes in drug research. They resent the export of clinical trial work, which they blame not only on industry's endless pursuit of lower costs but also on the increasing red tape surrounding trial procedures at home.
"Many of my colleagues have just thrown in the towel and say 'I'm not going to do clinical research anymore'," says Dr. Michael Crawford, professor of medicine and chief of clinical cardiology at University of California-San Francisco, one of the top medical schools in the United States.
"It's pervasive. They've just quit clinical trial work. It's just too difficult and the expenses are so high you end up being in the red when you do a study."

That's in stark contrast to the experience of doctors in Hungary, many on a monthly salary of around 500 euros ($740), for whom working on a clinical study can double their pay. For medics in places like India -- now also a major hotspot of clinical research -- the salary boost can be even greater.
But Crawford says he does not want data from these places. He wants to see how a new medicine performs in his own country.

"I don't have any way of assessing the quality of research in an Eastern European country. It may be wonderful, but I don't have any way of assessing that. I know if a study is conducted in the United States and Canada, it's done according to certain standards," he says.
Dr. David Holmes, president of the ACC and professor of medicine at the Mayo Clinic in Minnesota, is more circumspect but also believes the Brilinta case raises important issues: "We can't abrogate the responsibility of conducting clinical trials in the U.S. on people that live in the United States."
The EMA's Sweeney says there is no evidence that clinical trials conducted in developing economies are any worse than those done in the West. However, lack of evidence is not the same as positive proof and his team needs more resources to guarantee everything is squeaky clean on the front-line. Between 2005 and 2009, the European watchdog dealt with data linked to pivotal studies from 44,034 clinical trial sites, but it carried out only 44 good clinical practice inspections outside Europe and North America. The U.S. FDA, meanwhile, inspected 0.7 percent of foreign clinical trial sites in 2008, against 1.9 percent of domestic sites.

CHINA RISING
For now, the world's emerging economies still play second fiddle to the United States when it comes to testing drugs. Clinicaltrials.org, a website run by the U.S. National Institutes of Health, currently lists more than 106,000 trials around the world, of which just over 50 percent are in the United States. But the balance is shifting, particularly when it comes to the big late-stage trials that really matter in deciding whether a drug is approved for sale. U.S. centers account for only 43 percent of the nearly 19,000 trials in final Phase III testing.

As in so many other areas of life, the rising star is China, which already has a total of more than 2,700 clinical trials and is experiencing exponential growth.

Less than two hours by high-speed train from Shanghai, Dr. Zhang Chenyu's modern laboratory at Nanjing University's School of Biological Science shows how Chinese medical research has vaulted up the global league table. After nine years working as a research assistant professor at Harvard Medical School, Zhang returned to China in 2004, where he is dean of the Nanjing school, and these days he finds the world's top drugmakers beating a path to his door.

Zhang is a bit special because he and colleagues have discovered how certain molecules, or biomarkers, in blood can signal the presence of cancer as early as 33 months before conventional clinical diagnosis. As a result, his team is testing hundreds of U.S. blood samples in a lung cancer project with Johnson & Johnson, which is interested in developing a new diagnostic test using the biomarker. But Zhang is also convinced the wider Chinese research community has arrived firmly on the global clinical research scene, thanks to its relatively low cost base, its expertise, its modern facilities and -- crucially -- the huge potential market for Western medicine in the country.

China has already leapfrogged the likes of Germany and France to become the world's third largest market for pharmaceuticals, and by 2015 it is set to overtake Japan as the second-biggest, behind only the United States, according to pharmaceutical market information company IMS Health.
"Drug companies will surely vie for such a market," says Zhang. "Now, more Chinese can afford to buy Western-made drugs. So instead of performing a trial in China only after completing trials in Europe or the U.S., why not conduct them all at the same time?"
Independent expert Dr. Rory Collins, a professor of medicine at the University of Oxford and co-director of its Clinical Trial Service Unit, is a big fan of the power that Chinese clinical research can bring to medicine and is deeply impressed by how far the country has come in two decades.

"I remember 20 years ago giving lectures on randomized trials in China and the idea that you would randomly allocate people to get treatment, or not, was viewed as completely alien. The response was: 'We know which treatment works, we just ask the professor.' Today, China is a very organized place and all the structures are there," he says.

Indeed, the results of Chinese drug research are already bearing fruit -- and not just for patients in China.
Six years ago, Collins's Oxford team led a huge 46,000-patient study in China -- the biggest ever seen in the country -- to test the blood thinner Plavix and a beta-blocker in the emergency treatment of heart attacks. They found that adding Plavix to aspirin produced further benefit, while the beta-blocker metoprolol did not. That important discovery has since gone on to influence medical practice around the world.
"That study would never have been done if we couldn't have run this very streamlined trial in China at very low cost," says Collins, who is currently working on another pivotal heart drug study for Merck that contains no U.S. patients. "My preference would be not to do any trial in North America because it is so inefficient and so costly."

Western Europe may be a bit better but Collins and many other researchers are highly critical of the bureaucratic obstacles there as well, following the introduction of the European Union's 2004 clinical trials directive, which has led to a mountain of extra paperwork for each trial.
The aim of the EU directive is to harmonize standards and protect subjects.

AVOIDING EXPLOITATION
Everyone agrees that patients should not be exploited during the testing of drugs but trying to square the circle on ethics leads to fierce debate. Enrolling in a clinical trial can be a big health boost for many patients in poorer countries, who receive better-than-normal healthcare while being studied. But is it right to test an expensive new drug in a country where local people may never be able to afford it? And do patients always understand the risks associated with testing an unlicensed drug?
Caring for patients properly means drug companies "not just parachuting in, doing a study and leaving without recognition that these patients have really made a contribution, taken some risks and deserve to be respected and provided with certain broader aspects of care", FDA Commissioner Margaret Hamburg told the Reuters Health Summit in November.

Annelies den Boer of the Dutch non-profit Wemos Foundation, which has been following the globalization of clinical trials since 2006, worries a lot about just that sort of exploitation -- and worse.
She is concerned that the current benchmark guidelines on good clinical practice from the International Conference on Harmonisation (ICH) -- agreed by U.S., European and Japanese regulators and accepted by the drugs industry -- are unbalanced in emphasizing efficiency over ethics. And she fears that the out-sourcing of a growing volume of clinical work by pharmaceutical companies to specialist firms known as contract research organizations, or CROs, makes proper oversight increasingly difficult.
"People in many developing countries are often poor or illiterate, which makes them vulnerable," she says. "It's very difficult to check if companies do indeed abide by ICH because governments in countries where these trials take place do not exercise a lot of control. There's an entire chain -- vulnerable patients, doctors with conflicts of interests, CROs that are geared to doing trials extremely fast -- which is detrimental to ethical guidelines."

Given the numbers involved, it's no surprise that some subjects come out of the process disillusioned, as highlighted in testimonials gathered recently by den Boer's team.
Take Barbara, a 30-year-old Polish woman, who was initially thrilled when her eight-year-old son Marek was chosen to test a new drug for attention deficit hyperactivity disorder (ADHD). She received 200 zlotys ($75) and, after about five weeks, the drug really seemed to work. Unfortunately, a short time later, the trial ended and the drug was withdrawn leaving Barbara both angry and deeply concerned about her son's future treatment.

"I can't believe I signed my son up for this trial without really understanding what I was agreeing to. I was blind. I realize now that people taking part in clinical trials should have the right to ask questions and be spoken to like human beings, not just guinea pigs," Barbara says.
Other subjects in Poland, Russia, China and India tell similar stories of the easy money that can be made from trials. But common complaints center on the lack of follow-up support and the impenetrability of jargon-filled contracts that can run to 50 or 60 pages.

Lifen, a 23-year-old graduate student living in Beijing, has taken part in five clinical trials to help pay for her studies. "The money is good, although recently I've noticed the payment rates have been going down. I think this is because there are more and more volunteers coming forward," she says.

Cases alleging serious side effects are rare, but not unknown. Pfizer Inc's 200-patient trial of the antibiotic Trovan during a 1996 meningitis outbreak in Kano, Nigeria, triggered a decade-long legal battle, after 11 children died and the company was accused of not obtaining adequate prior consent. It inspired John le Carre's novel "The Constant Gardener." Pfizer has always argued that meningitis and not its antibiotic led to the deaths. Still, two years ago the drugmaker reached a $75 million settlement with Kano state government to compensate victims, and in February this year it settled all remaining lawsuits on undisclosed terms.
Other controversial cases in recent years have involved the testing of AIDS drugs in Africa, breast cancer and anti-psychosis drugs in India, and vaccines in Latin America.

History suggests we need to remain vigilant -- and it is not only commercial operations that can be culpable. Last October, U.S. President Barack Obama personally apologized for an experiment conducted in the 1940s in which U.S. government researchers deliberately infected Guatemalan prison inmates, women and mental patients with syphilis.


ETHNIC DIFFERENCES
Today, the drugs industry insists, things are very different and its conscience is clear over the way modern clinical trials are conducted. The same strict standards apply to foreign trials as to those conducted domestically.

"We have exactly the same protocol and exactly the same standards for our trials around the world," says Roche Holding AG Chief Executive Severin Schwan, who is impressed by the modern hospitals he visits these days in places such as Brazil and China. "Some years ago quality might have been a real concern. Today the situation is different. This is a reason why more trials are being conducted in emerging markets."
The Swiss company, the world's largest maker of cancer drugs, is also doing more trials in these places because the healthcare authorities there want to see data collected from their own populations.

"I see this as an opportunity. A broader range of patients can take part in our trials and the patient population of our trials becomes ethnically more diverse ... If we do not include a certain portion of patients in our global trials, some countries might delay the approval of certain drugs," Schwan says.

That ethnic issue is important. As drug treatments become more targeted, scientists are unraveling how small genetic variations may make one medicine suitable for a particular group of people. AstraZeneca's lung cancer drug Iressa, for example, failed to help Western patients overall in tests but proved much more effective in Asians -- a discovery that has shed valuable new light on ways of tackling the disease worldwide.
"We are starting to understand ethnic differences through the responses seen in global trials. If each of us were an island unto himself, there would be no way we could make this comparison," says Dr. David Kerr, president of the European Society for Medical Oncology. "By cherishing our genetic diversity we can identify biomarkers like the one for Iressa. That is really exciting."

For drug companies looking to globalize their vast portfolio of clinical trials it all boils down to two over-riding factors -- time and money. And in this business, where the clock is always ticking down to the next drug patent expiry, time also means money because shaving six months off drug development timelines can spell hundreds of millions of dollars of extra sales.

So it is perhaps surprising that many in the industry are still struggling to work out just how much cheaper it really is to do clinical research in faraway places.

Back in 2008, former GlaxoSmithKline Plc Chief Executive Jean-Pierre Garnier gave a startling estimate of savings in an article for the Harvard Business Review, when he said a midsize company with 60,000 patients in clinical trials could save $600 million a year by switching 50 percent of its trials to low-cost places such as India and Latin America. A top-rate academic medical center in India would charge just $1,500 to $2,000 per patient case report, while a second-rate U.S. center would bill $20,000, he said.

In practice, things are a bit different, according to Kenneth Getz, senior research fellow at the Tufts Center for the Study of Drug Development in Boston. He believes off-shoring clinical research is not quite the bargain many drugmakers had thought. Getz reckons the per patient cost of running a trial in India and China is probably about half what it would be in Western Europe or the United States -- a big margin, of course, but considerably less than Garnier had suggested. And then there is the considerable extra cost of managing multiple studies across myriad sites.

"The economics are not nearly as attractive as once thought," Getz says. "Clearly, companies want to test their drugs in markets where they hope to commercialize a new treatment, so that is a driver for deciding where to conduct clinical studies. But given the increased operating costs and the inefficiencies, which can sometimes result in delays in some parts of the world, I think companies will begin to rethink just how many countries they wish to use."

FAIR PAY OR BRIBE
Reputational issues, too, may weigh on gung-ho Western drugmakers -- not only because of the rising public profile of the issue but also as a result of some new legal questions. In the United States, the Justice Department has mounted an investigation under the Foreign Corrupt Practices Act to see if drugmakers are offering overseas bribes, and clinical trials are firmly in the spotlight. That's because doctors in many countries are government employees and therefore any payments to them deemed above fair market value might be viewed as bribes. Britain, too, is introducing a strict new Bribery Act in July that also covers such overseas payments.

"Companies have to be aware that there is a legal power here and there is the possibility of prosecution," says Lincoln Tsang, a partner at the London offices of law firm Arnold & Porter LLP. "It adds a level of uncertainty and companies will have to do more due diligence to ensure that any new clinical trial site will really add value to the existing network."

In the offices of the European Medicines Agency in London and the FDA in Washington, plans are afoot to ramp up inspections of foreign clinical trial sites to check protocols are being followed and there is no risk of dodgy data that could skew approval decisions in the West and jeopardize patient safety. Getz expects both agencies to audit many more sites this year and next to address these concerns.
Yet the action will only scratch the surface and the small teams on tap at the EMA and FDA will be able to check only a fraction of the tens of thousands of trials conducted outside their own territories.
Back in Hungary, Dr. Horvath is very confident about the way clinical trials have been conducted over the years at his hospital and has the raw data going back decades to prove it. "Obviously you need to follow good clinical practice and stick by all the ethical criteria," he says.

But he is still waiting for the first knock on the door from the FDA. (Additional reporting by Ransdell Pierson in New York, Ee Lyn Tan in Hong Kong and Katie Reid in Zurich; Editing by Jim Impoco and Claudia Parsons) ऀ

Chinese Regime’s Organ Harvesting:China’s use of organs harvested from executed prisoners and unidentified sources

Related; Organ Harvesting In China
Reality Check: The Outsourcing Of Clinical Trials/Drugs

Transplant Community Responds to Chinese Regime’s Organ Harvesting
By Pamela Tsai
EpochTimes Staff
May 4
China’s forced organ harvesting is an inescapable responsibility for the global transplant community, including transplant patients, voiced a panel of experts in Philadelphia on May 1. Held alongside the 2011 American Transplant Congress, the panel discussion, titled Global Transplant Community at Medical Crossroads, saw a hotel ballroom full of participants.

Hosted by the NGO Doctors Against Forced Organ Harvesting (DAFOH), the panel raised the question of how the transplant community in the West should respond to China’s use of organs harvested from executed prisoners and unidentified sources, an unacceptable practice according to the international medical thical standards.

Pharmaceutical Companies
International pharmaceutical companies have played a major role in helping to perpetuate the unethical practice of organ harvesting through their drug trials in China, according the speakers at the panel discussion.

Dr. Eric Goldberg, senior medical director of ICON, a global clinical research company, pointed out that the low cost of developing clinical trials in China—roughly 15 percent of that in the United States—makes it very appealing to the pharmaceutical companies that try to develop drugs with a limited budget in a recessive economic environment, adding that China also offers the companies the extra benefit of speeding up the drug development process by having a large number of patients and fewer regulations.

“The issues that we deal with at the FDA, the EMA, [and] Health Canada, they just don’t exist in China. There’s much less scrutiny” Dr. Goldberg said.

Yet while many international pharmaceutical companies have carried out research in China, not many are ready to acknowledge their roles on the issue of China’s unethical organ harvesting, according to the panel’s speakers.

The well-known human rights lawyer David Matas, who co-authored the book, Bloody Harvest: Organ Harvesting from Falun Gong Practitioners in China, with David Kilgour, singled out the Swiss pharmaceutical company Roche as example.
According to Matas and Kilgour’s investigation in the years 2002-2006 there were 41,500 transplant operations for which the Chinese regime could not provide a source. They believe detained Falun Gong practitioners are the most likely source for these organs.

While being questioned about the issue of unidentified organ sources in relation to its transplant patients in China, Roche’s response, as Mr. Matas showed in his slide on Sunday’s panel discussion, was “Roche is not in charge of the supply of organs … Roche is not entitled to know the source of transplant organs.”

Roche’s former CEO and present chairman of the board of directors said, “In China there were no ethical or cultural stoppages for transplant medicine,” according to Mr. Matas, who noted that the statement is an acknowledgement of Roche’s knowingly conducting clinical trials in China while not showing concern for the unethical practices behind them.

Ignorance on the part of the companies about the sources of transplanted organs is not an acceptable reason in the eyes of the panel’s speakers.
“They can’t say they don’t know where the organ came from. They can’t say they don’t care where the organ came from” said Dr. Caplan, professor of Bioethics at the University of Pennsylvania in Philadelphia, who was one of the panel’s speaker and is also the keynote speak of the 2011 American Transplant Congress.

Roche won two shame prizes in 2010: the Public Eye Swiss Award and the Public Eye People Award for “irresponsible corporate behavior.” A Dutch investment bank Triodos disinvested from Roche in September 2010
Mr. Matas reported a watch list of multinational pharmaceutical companies that have conducted clinical trials on organ transplant anti-rejection drugs in China, including Wyeth (now part of Pfizer), Novartis, Roche, and Astella. These trials were performed on patients who receive organs harvested in China.

Last month, on the issue of China’s unethical organ harvesting, The Epoch Times tried to solicit comments from a number of pharmaceutical companies, and four companies are on Mr. Matas’s watch list. Both Isotechnika, a biopharmaceutical company based in Alberta, Canada, and Norvatis, a Basel-based pharmaceutical company, have responded.

Launa Aspeslet, a representative of Isotechnika, told The Epoch Times on the phone that the company became aware of the issue and would send a representative to attend the panel discussion to learn more about it. And the representative did attend the Sunday panel discussion.

Eric Althoff, a media spokesperson of Norvatis, provided a written response via e-mail.

The statement says that Novartis supports the Declaration of Istanbul and the United Nations Declaration of Human Rights, adding, “We are committed to work with authorities and transplant societies to raise public awareness about organ donation and to ensure that highest international standards are adopted and observed."

Professional Responsibilities
The panel’s speakers unanimously agreed that it’s high time for the global transplant community to step up in ending the unethical organ harvesting practice in China.

The lack of scrutiny in China doesn’t exempt transplant medical professionals from their responsibility to keep up with the international standard in medical ethics.

Another panel speaker, Dr. Gabriel Danovitch, medical director for the Kidney & Pancreas Transplant Program at the Department of Medicine of UCLA, said the global transplant community has power to effect a positive change on the Chinese government.

“We don’t have cruise missiles or tanks. But we do have some power by virtue of professional acceptance.”

He expressed deep concerns about the lack of critical eyes on China in the transplant community. Leading medical journals’ editorial boards keep accepting research papers from China on organ transplant.

An example Dr. Danovitch used in his slides was an article published in the American Journal of Transplantation last year, which has a sentence that provides no critical scrutiny on China’s dubious organ harvesting practice.

“The Chinese procedure also has the advantages of being very accessible and relatively inexpensive as compared to Western centers. … It is also possible to procure an organ in a relatively short time,” according to Dr. Danovitch.

He encouraged the western transplant society to use the power to make a positive change in China. “If we don’t exercise it, we’ll fritter it away,” he said.

Dr. Goldberg gave a personal testimony of how he exercised his professional power. After knowing about the organ-harvesting situation in China, he went to persuade his company not to include China in its clinical trials.

“Fortunately for me personally and fortunately for the world, I received the backing that I needed,” said Dr. Goldberg, who was very happy for and proud of his company—ICON.

“There are commercial implications here of a multibillion dollar world famous company to do the right thing, so I became proud of that,” he said.

Mr. Erping Zhang, spokesperson of Falun Gong and one of the panel’s speakers, emphasized the importance for transplant professionals to take full responsibility on the issue.

“History will not only judge on what we have done, but also on what we didn’t do while we could,” said Mr. Zhang.

The atrocity of organ harvesting from living practitioners of Falun Gong in China is the focus of the documentary Between Life and Death, an award winner in the “Investigative Reporting/News Documentary” category in the 2011 Hugo Television Awards.

E-mails and phone calls to Pfizer and Astellas have not been returned.
Read More: Professional Responsibilities

In Todays News;
Illegal trade of placenta unearthed in China
Beijing, May 7 (IANS) Human placentas are being illegally sold for 20 yaun (about $3) each at a hospital in southern China, a media report said Saturday. Placentas are considered a rich source of nutrients by some people. The incident came to light during an undercover operation at the Red Cross Hospital in Guangzhou city of Guangdong province, according to Shanghai Daily. Health authorities have launched a probe. Placentas were banned from trade following a health ministry order in 2005 due to health concerns. They supply oxygen and nutrients to the fetus during pregnancy and allow fetal waste to be disposed of via the mother’s kidneys. The placenta can be infected during labour or carry viruses such as hepatitis B from the mother, say doctors.

The undercover operation was launched by a reporter of the New Express Daily after a whistleblower revealed that the nurses at the hospital’s obstetrics and gynaecology department were carrying out the illegal trade. The nurses collected the placentas after women gave birth and kept in a fridge in an office. The whistleblower revealed that his wife, who had given birth at the hospital last year, had her placenta taken away without receiving any notification. After receiving 20 yuan from the reporter, the chief nurse took out one in a plastic bag and told the scribe that it should be stewed with lean meat and Chinese dates for about an hour. The accused would face punishment if proved guilty, officials said

China’s Hepatitis C Virus Market Will Grow to $247 Million in 2015

China’s Hepatitis C Virus Market Will Grow to $247 Million in 2015
Decision Resources

Posted on:24 Mar 11

More Decision Resources press releases
Decision Resources, one of the world’s leading research and advisory firms for pharmaceutical and healthcare issues, forecasts that the hepatitis C virus (HCV) market in China will grow from $137 million in 2010 to $247 million in 2015. According to the Emerging Markets report, Hepatitis C Virus in China, a large patient population and expansion of government-sponsored health insurance and reimbursement of high-priced HCV therapies are among the drivers that will contribute to growth in this market.

“China has the largest HCV patient population in the world—more than five times the number of HCV infection cases in all seven major pharmaceutical markets combined,” said Decision Resources Analyst Jing Wu, M.S., M.B.A. “The percentage of HCV patients in China who are diagnosed is low, but we anticipate a small increase in diagnosis rates that will lead to a significant expansion of the overall drug-treated patient population in China.”

The report also finds that while peg-IFN-alpha agents Roche’s Pegasys and Merck’s PegIntron are recommended as first-line therapy by the Chinese HCV Prevention and Treatment Guidelines, their uptake has been limited because of high treatment costs. Peg-IFN-alpha agents have been included in the 2009 National Reimbursement Drug List in China, with a reimbursement rate that ranges from 50 to 90 percent and varies by region.

“The partial reimbursement of the treatment cost of peg-IFN-alpha agents will expand the patient population that can afford these high-priced treatments, especially in urban regions,” said Ms. Wu. “However, high copayment will continue to pose a big financial burden on patients, and more than a third of the urban population has not yet been covered by a government-sponsored health insurance program.”

The new report features extensive primary research with Chinese gastroenterologists, hepatologists and infectious disease specialists as well as a market outlook through 2015.

About Emerging Markets Reports

Decision Resources is the first and only company to offer a syndicated report series for high-growth emerging markets with comprehensive disease-specific analysis. Each report assesses the commercial opportunity in the pharmaceutical market for a disease based on population demographics, economic development, disease epidemiology and changing physicians’ practices.

About Decision Resources

Decision Resources (www.decisionresources.com) is a world leader in market research publications, advisory services and consulting designed to help clients shape strategy, allocate resources and master their chosen markets. Decision Resources is a Decision Resources, Inc. company.

About Decision Resources, Inc.

Decision Resources, Inc. is a cohesive portfolio of companies that offers best-in-class, high-value information and insights on important sectors of the healthcare industry. Clients rely on this analysis and data to make informed decisions. Please visit Decision Resources, Inc. at www.DecisionResourcesInc.com .

All company, brand or product names contained in this document may be trademarks or registered trademarks of their respective holders.

Business Wire
http://www.businesswire.com /

Last updated on: 24/03/2011 14:00:39

Read more: http://www.pharmiweb.com/pressreleases/pressrel.asp?ROW_ID=38159#ixzz1HWimKs00

The Task; FDA's Overseas Inspections

The U.S. pharmaceutical industry has jumped on the outsourcing phenomenon, which in the past has posed major risks for American consumers.
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According to an article in the Berkeley wellness letter; "What matters is that drugs manufactured in the U.S. are regulated according to strict standards, and manufacturing facilities undergo periodic inspections by the Food and Drug Administration (FDA), a federal agency. Canada and the European Union have their own standards, but this is not generally true elsewhere, not even Japan. Technically, the FDA is supposed to register all exporters to the U.S. and do a pre-approval inspection of any plant supplying drugs to the U.S. But that seldom happens. For one thing, products often go through many hands. The importer may not even know where they came from. In 2006, according to an article in Clinical Pharmacology and Therapeutics, the FDA inspected 212 foreign drug firms, but there are thousands more. It is a job of overwhelming proportions."

While the FDA strives to regulate the complex supply of drugs from U.S. drug manufactures, the officials also take on the seemly difficult task overseas. Pharmalot, one of my favorite blogs and maybe yours too, has put together another great article on the FDA's attempt at regulating drug manufacturing overseas. Noted by the author Ed Silverman "In China alone, the problem is daunting. There are nearly 1,000 manufacturers of drug substances eligible for FDA spection."
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Global drug manufacturing has increased substantially, take a look at the Pharmalot article to gain some insight into the growing numbers and the FDA's task at hand.
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