Big Pharma CEOs Rake in $1.57 Billion in Pay


Posted: 05/08/2013 8:19 am | Ethan Rome, Huffingtonpost

For people who were blown away to learn recently that the 11 largest global pharmaceutical companies made an astonishing $711 billion in profits over the last decade, here’s another measure of the industry’s greed: the same companies paid their chief executive officers a combined$1.57 billion in that period. Not bad work if you can get it. They achieved this thanks in part to their systematic exploitation of Medicare and an epidemic of illegal marketing activity.

According to corporate filings analyzed by Health Care for America Now (HCAN), in 2012 the drug companies’ CEOs drew total compensation of $199.2 million, two and a half times the total in 2003. In 2006, the first year of the Medicare prescription drug law, the pay of the CEOs jumped by $58.9 million from the previous year, the largest one-year increase in the decade HCAN reviewed.

Inflated Drug Prices

These huge spikes in pay coincided with eye-popping profits bolstered by a provision the pharmaceutical lobby inserted into the law to prohibit Medicare from using its unparalleled purchasing power to obtain discounts or negotiate prices with drug companies. By prohibiting Medicare to get better drug prices, the federal government is effectively subsidizing the greed of the drug makers and their CEOs. As a result, Americans pay vastly higher prices than people in other countries for identical drugs. This is ludicrous and wasteful. It hurts the government, seniors and middle-class families.

It should not be the official policy of the United States to price-gouge our people and government – a practice that’s especially offensive at a time when some in Washington are talking about cutting Medicare benefits. Simply empowering Medicare to buy drugs under the same bulk purchasing discounts used by state Medicaid programs would save the federal government billions. For example, the Medicare Drug Savings Act, introduced by Sen. Jay Rockefeller (D-WV), would save $141 billion over the next 10 years without reducing Medicare benefits. Similar measures are in President Obama’s budget proposal and the House Democratic budget plan.

Illegal and Improper Conduct on the Rise

The increases in CEO pay and drug company profits also corresponded with a surge in illegal and improper conduct by the industry. From 2003 to 2012, financial penalties paid by drug manufacturers to settle allegations of illegal marketing, price-gouging of government programs and other violations rose by more than 500 percent, according to a report issued by Public Citizen in September 2012.
In 2003, there were only nine settlements with the federal or state governments, amounting to $967 million in penalties. In 2011, federal and state government agencies reached a record 44 settlement agreements with drug makers. And by July 2012, with the year only half over, drug companies had already agreed to pay nearly $6.6 billion as part of 19 settlements with the government. Data on the second half of 2012 have not yet been compiled by Public Citizen.

Here’s the kicker: The most common drug-company violation cited by regulators and law enforcement agencies between 1991 and July 2012 was overcharging government health programs. Really? How much overcharging do they need?

Over the last decade, the drug companies racked up unprecedented penalties for criminal and civil violations. They jacked up prices for seniors and the government. They made excessive profits and gave unconscionable compensation to the CEOs in charge of this all.

End Corporate Tax Giveaways

It is obscene that any lawmakers in Washington — even the most extremist Republicans who hate civilization as we know it — are even talking about cutting benefits for seniors in the midst of what amounts to a drug industry scandal.

We shouldn’t be making any benefit cuts to Medicare, Medicaid, the Affordable Care Act or Social Security. Not now, not ever. Instead, we should make the wealthiest Americans pay their fair share in taxes and eliminate indefensible special-interest tax breaks and subsidies for big corporations like the companies that ship jobs overseas, Big Oil, and a drug industry that has made a science out of ripping off the American people.

* * * * *
HCAN’s analysis of CEO pay focused on 11 companies: Johnson & Johnson, Abbott Laboratories, Pfizer, Novartis, Eli Lilly, Roche, Merck, Bristol-Myers Squibb, Sanofi, GlaxoSmithKline and AstraZeneca. Over the 10-year period, the $1.57 billion in total compensation was split among 27 executives. The top earners in 2012 were Johnson & Johnson’s William Weldon, who took in $29.8 million, and Pfizer’s Ian Read, who received $25.6 million. By comparison, the median household income in the U.S. last year was $50,054, while half of all Medicare beneficiaries had less than $22,500 in annual income.

Click below for details on Big Pharma’s annual CEO compensation expenditures.

http://healthcareforamericanow.org/wp-content/uploads/2013/05/ceo-earnings-table-2013-0507-for-web.pdf 

In April, HCAN compiled data showing that the 11 drug companies
reported$711.4 billion in profits over the same 10-year span.

 

US court pays $6 million to Gardasil Vaccine Victims #goodnews


Wednesday, April 10, 2013 – Alternative Health with Dr. Lind by Peter Lind

WASHINGTON, April 10, 2013 – Gardasil, the vaccine for HPV (human papillomavirus), may not be as safe as backers claim.

Judicial Watch announced it has received documents from the Department of Health and Human Services (HHS) revealing that its National Vaccine Injury Compensation Program (VICP) has awarded $5,877,710 dollars to 49 victims in claims made against the highly controversial HPV (human papillomavirus) vaccines. To date 200 claims have been filed with VICP, with barely half adjudicated.

“This new information from the government shows that the serious safety concerns about the use of Gardasil have been well-founded. Public health officials should stop pushing Gardasil on children.” said Judicial Watch President Tom Fitton.

The CDC recommends the Gardasil vaccine, made by Merck Pharmaceuticals, for all females between 9 and 26 years to protect against HPV. Furthermore, the CDC says Gardasil is licensed, safe, and effective for males ages 9 through 26 years.

The facts appear to contradict the FDA’s safety statements. The adverse reaction reports detail 26 new deaths reported between September 1, 2010 and September 15, 2011 as well as incidents of seizures, paralysis, blindness, pancreatitis, speech problems, short term memory loss and Guillain-Barré Syndrome. The documents come from the FDA’s Vaccine Adverse Event Reporting System (VAERS) which is used by the FDA to monitor the safety of vaccines.

That’s 26 reported deaths of young, previously healthy, girls after Gardasil vaccination in just one year.

In response to the concern about death reports among those who received Gardasil, the Centers for Disease Control (CDC) insists  “there was no unusual pattern or clustering to the deaths that would suggest that they were caused by the vaccine.”

While it is not clear exactly what is causing so many adverse reactions, Gardasil does contain genetically engineered virus-like protein particles as well as aluminum, which can affect immune function.

Further, according to the vaccine manufacturer product information insert, “Gardasil … not been evaluated for carcinogenicity or impairment of fertility.” (2007 [227] p1986 )

In fact, Merck studied the Gardasil vaccine in fewer than 1,200 girls under 16 prior to it being released to the market under a fast-tracked road to licensure. To date, most of the serious side effects, including deaths, that occurred during the pre-licensure clinical trials and post marketing surveillance have been written off as a “coincidence” by Merck researchers and government health officials.

Neurologist Dr. Ian Sutton reported negative neurological side effects from Gardasil. He reported five cases of multiple sclerosis-like symptoms emerging shortly after women received the Gardasil vaccine, noting:

“We report five patients who presented with multifocal or atypical demyelinating syndromes within 21 days of immunization with the quadrivalent human papilloma virus (HPV) vaccine, Gardasil. Although the target population for vaccination, young females, has an inherently high risk for MS, the temporal association with demyelinating events in these cases may be explained by the potent immuno-stimulatory properties of HPV virus-like particles which comprise the vaccine.”

From its inception, the use of HPV (human papillomavirus) vaccines for sexually transmitted diseases has been hotly disputed.  According to the Annals of Medicine: “At present there are no significant data showing that either Gardasil or Cervarix (GlaxoSmithKline) can prevent any type of cervical cancer since the testing period employed was too short to evaluate long-term benefits of HPV vaccination.”

There are more than 100 types of human papillomaviruses (HPVs). Of them, about 40 types of HPV are sexually transmitted and 15 of these types are most associated with cervical cancers and genital warts in women and men.

HPV vaccines have been illegally administered to millions without informed consent, as the risks rarely disclosed.

Not only are there questions about the safety of the vaccine, there are questions about the need for the vaccine. Over 90 percent of women infected with HPV clear the infection naturally within two years, at which point cervical cells go back to normal.

Meanwhile, Merck is benefitting tremendously from vaccine sales. The vaccine is expected to reach $1 billion in sales next year, and could reach more than $4 billion in sales in five years, according to Wall Street analysts.

Dr Peter Lind practices metabolic and neurologic chiropractic in his wellness clinic in Salem, Oregon. USA. He is the author of 3 books on health, one novel, and hundreds of wellness articles. His clinical specialty is in physical, nutritional, and emotional stress.

 

The Indian Academy of Paediatrics (IAP)’s reforms: transformative or cosmetic? #medicalethics


Rema Nagarajan
25 February 2013, 08:14 PM IST, TNN

The Indian Academy of Paediatrics (IAP)’s has dismantled its Committee on Immunisation which recommends vaccines to be included in the annual immunization schedule. It is being reconstituted as IAP Advisory Committee on Vaccines and Immunisation Practices. (ACVIP).

The IAPCOI, which was almost entirely funded by vaccine manufacturers, was under a cloud following criticism about issues of conflict of interest.

In IAP’s new committee on immunization members have to abide by a very strict code of conduct and also have to sign a pretty exhaustive declaration of conflict of interest stating whether they, their employer or their immediate family members have received any money or travel grant or favour from a commercial business, industry association or research association or other enterprises with an interest related to the subject of the meeting or work. The declaration also includes statements about research support including grants, collaborations, sponsorships and other funding the person or his department or research unit might have received. It also includes non-monetary support for research such as equipment, research assistants, facilities, paid travel to meetings, investments such  as stocks, bonds, securities, in a commercial and so on. Plus, the members have to have undergone some training in the field of immunization and vaccines.

The brand name Rotarix is prominently displayed inside the hall of the PEDICON conference held last month, though IAP claims it does not promote brands

The brands Synflorix and Rotarix of GSK, a major sponsor of the conference displayed prominently all over the conference venue

Doctors thronging the stalls put up by various pharma companies especially vaccine manufacturers

Secretary general of IAP Dr Sailesh Gupta pointed out that all doctors’ associations take money, whether it is gynaecology association or the cardiology association of India, as they cannot conduct training without pharma support.

“Why only pharma? There should be concern about us taking funding from WHO or the UNICEF. Even they have an agenda. For example, UNICEF also promotes food products for children. So, even with these international agencies they will want to promote a particular food product they are using in say Africa. So, we need to be careful with them also,” said Dr Gupta. He added that there were very few organisations which were doing something about conflict of interest like the IAP.

Dr Gupta said that Medical Council of India (MCI) was not responsive to doctors’ concerns. “MCI never responds to any letter we send. Sometime back we were organising two conferences which were being funded by pharma companies. We wrote to the MCI seeking clarification regarding this. We got no response from them. Finally, we hired a lawyer specialised in MCI regulations who assured us that there was nothing amiss in conducting the conference. If MCI clarifies that organisations cannot take funds at all from pharma we will abide by that.”

He further explains: “We understand that the public has concerns about conflict of interest in us taking funding from pharma. But when we make recommendations we give an entire armament of medication for a condition and not by brand name. We ensure that pharma does not advertise inside the area where the programme is taking place even when a company is funding a session or workshop or training. We only use generic names and the only credit is to say that the programme is supported by so and so company. We are very careful about conflict of interest.”

While it is true that IAP is making efforts to address conflict of interest in its immunisation committee, it is not entirely true that IAP does not promote brands or that they do not allow advertising inside where programmes take place. A few photos from IAP’s annual conference Pedicon held just last month, show that industry particularly vaccine industry was visible everywhere and even during sessions their advertisements were being projected. Members were also being given gifts by companies at their stalls.

Is this a case of more things change, the more they remain the same? Or, is there a genuine effort to change illegal funding practices and address conflict of interest issues?

Supreme Court admits PIL on cancer cervical vaccine trial #goodnews


TNN | Jan 8, 2013,

INDORE: The Supreme Court on Monday admitted a public interest litigation (PIL) filed by local activists alleging that pharma companies had conducted unauthorised drug tests of their vaccine on tribal girls.

The petition alleges that pharma companies, including Glaxo Smithkline and MSD Pharmaceuticals Pvt Ltd tested gardasil and cervarix — two unproven HPV vaccines purported to prevent cervical cancer — on nearly 24,000 tribal girls in Andhra Pradesh and Gujarat, including 44 persons at the Maharaja Yeshwantrao Hospital (MYH). Of 44 patients subjected to drug trials in the state, 10 were males.

PIL filed by Kalpana Mehta of Indore, Nalini Bhanot and V Rukmini Rao representing Gramya Resource Centre for Women alleges that the testing had led to adverse effects on girls’ health and the pharma companies ignored their further treatment. Seven girls allegedly succumbed during the vaccine trial. The petitioners were represented by Colin Gonsalves of the Human Rights Law Network.

Admitting the case, Justice S Radhakrishnan and Justice Dipak Misra have directed the Union government to immediately file its reply on the issue.

The apex court has also directed that the Christian Medical College, Vellore, should be asked to examine the medical record of the girls in question and submit a report to the court.

This order comes in the backdrop of allegations by activists that multinational companies are influencing state governments to carry out clinical trials on humans, which are often not transparent or regulated efficiently. The PIL alleges that PATH, an NGO, had initiated a project for the introduction of the two vaccines in India by signing a MoU with ICMR even before they were licensed by the Drugs Controller of India.

 

Asian countries act to get cheap drugs #rightohealth


SouthViews

No. 37, 22 October 2012
SOUTHVIEWS is a service of the South Centre to provide opinions and analysis of topical issues from a South perspective.
Visit the South Centre’s website: www.southcentre.org.

Staring with Malaysia in 2003, many Asian countries are now taking actions to promote cheaper medicines through compulsory licensing, with Indonesia being the latest case
………………………………………………………………

By Martin Khor

By Martin Khor
Recent government actions by Indonesia and India to issue compulsory licenses are extending the trend in Asia to increase access to cheaper medicines to treat serious ailments, especially HIV/AIDS, cancer and hepatitis B.

The supply of generic medicines, either through import or local production, has been the major method of reducing prices and making the drugs affordable to more people.

When the required medicines are patented, which usually results in high prices,   governments are allowed by the WTO rules to issue a compulsory license to enable themselves or private companies to import or produce generic versions, which usually cost much less.

In 2003, Malaysia became the first developing country to issue a compulsory license to a local firm to import drugs to treat HIV-AIDS from India.  The cheaper generic drugs enabled the government to treat many more patients within the same budget.

Following this, Indonesia in 2004 issued a Presidential decree enabling the production of a some HIV-AIDS drugs while Thailand in 2007 issued compulsory licenses for several HIV-AIDS and cancer drugs.

In March this year, India approved its first compulsory license enabling a local company to produce a generic version of an anti-cancer drug, which could reduce the price of treating kidney and liver cancer from US$5,200 a month (the price of the branded product) to $160 a month (the price of the generic product).

The latest measure was taken on 3 September by Indonesian President Dr. Susilo Bambang Yudhoyono who issued a decree which has the effect of a compulsory license.  It enables local manufacturers to make, import and sell generic versions of seven patented drugs used for treating HIV-AIDS and hepatitis B.

The decree said that in line with the urgent need to control HIV/AIDS and Hepatitis B in Indonesia, “it is necessary to continue and expand the access policies to provide access to antiviral and anti-retroviral medicines still protected by patent.”

This is the third time Indonesia has issued a set of compulsory licenses. The latest decree stated that the 2004 and 2007 decrees were no longer sufficient to implement the policies.

The compulsory license is aimed at significantly reducing the prices of these life-saving medicines and making them accessible to thousands more Indonesian patients.

“We will ensure the availability of good-quality, safe and effective generic versions of anti-retroviral and anti-viral drugs,” said HM Subuh, infectious disease control director at the Indonesian Health Ministry, as quoted in the Jakarta Post of 19 October.

According to the decree, the generic companies would have to pay a royalty of 0.5% of the net sales value of the generic drugs to the companies that own the patents, such as Merck, Glaxo SmithKline, Bristol Myers Squibb, Abbott and Gilead.

The first decree in 2004 enabled cheaper generic medicines that provided HIV-infected patients with first-line anti-retroviral therapy.  However, these have become ineffective or less effective because of increasing resistance or the lower safety of the drugs.

The latest decree enables the supply of generic anti-retroviral products for not only better first but also second-line anti-retroviral therapy.

“With the 2012 regulation, we obviously can improve access to quality but affordable drugs,” Maura Linda Sitanggang, the Health Ministry’s Director General for Pharmaceuticals and Medical Equipment, told The Jakarta Post. “We’re using this mechanism concerning public interest on the production of quality but affordable medicines to treat HIV and HBV.”

The seven medicines which are the subject of the compulsory license (known in this case as for “government use”) are efavirenz, abacavir, didanosin, lopinavir + ritonavir combination, tenofovir, tenofovir + emtricitabine, and tenofovir + emtricitabine + efavirenz.

All the drugs are used to treat HIV-AIDS.  The drug tenofovir (brand name Viread produced by patent holder Gilead) is also used to treat hepatitis B, which affects 13 million people in Indonesia.  It had been approved in the United States for treating HIV-AIDS in 2001 and for treating chronic Hepatitis B in 2008.

The combination drug tenofovir + emtrisitabin (brand name Truvada, produced by Abbot) is taken in a single dose once a day.  It has been used to treat HIV-AIDS and in July 2012 it also became the first drug approved by the US Food and Drug Administration for use as a preventive measure, to reduce the risk of HIV infection to people at high risk of infection including those who may engage in sex with HIV infected patients.

The Indonesian decree was the second compulsory license in Asia this year.

In India, the Patent Office in March approved the country’s first compulsory license to a local firm Natco Pharma to make a generic version of the cancer drug sorofenib tosylate (brand name Nexavar, produced by Bayer).

It was argued that at the high price of 2.8 lakh rupees (US$5,200) for a month’s dosage of Nexavar, only 200 patients were treated in India in a year.  Natco said that 8,000 people would need the drug, and it could supply a generic version at 8,800 rupees (US$160) for a month’s treatment.

The drug is used to treat advanced kidney and liver cancer.  According to the terms of the license, Natco would pay Bayer royalties of 6% of its net sales.

Bayer challenged the compulsory license and on 16 September the Intellectual Property Appellate Board rejected its petition, ruling that “If a stay is granted it will jeopardise the interests of the public who are in need of the drug.”

Other developing regions have also been making use of the compulsory license option in the WTO’s intellectual property treaty known as TRIPS.  They include Brazil and Ecuador in Latin America and Kenya, Zambia and Zimbabwe in Africa.

In 2001, the WTO’s Ministerial Conference in Doha adopted a TRIPS and Public Health Declaration that asserted that the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health.

It affirmed that the Agreement should be interpreted in a manner supportive of the right to health and access to medicines for all.

The Declaration clarified:  “In this connection, we reaffirm the right of WTO Members to use, to the full, the provisions in the TRIPS Agreement, which provide flexibility for this purpose.”

Table: Active Substance Name, Name of Patent Holder, Patent Number, and Duration of Patents for Antiviral and Antiretroviral Medicines
 

NO. NAME OF ACTIVE SUBSTANCES NAME OF PATENT
HOLDERS
PATENT NUMBER DURATION OF
PATENT
1. Efavirenz Merck & Co., INC ID 0005812 Until the end of patent period,
August 7, 2013
2. Abacavir Glaxo Group
Limited
ID 0011367 Until the end of
patent period, May 14, 2018
3. Didanosin Bristol – Myers
Squibb Company
ID 0010163 Until the end of
patent period, August 6, 2018
4. Combination Lopinavir and
Ritonavir
Abbott
Laboratories
ID 0023461 Until the end of
patent period, August 23, 2018
5. Tenofovir Gilead Sciences,
Inc.
ID 0007658 Until the end of
patent period, July
23, 2018
6. Combination Tenofovir and
EmtrisitabinCombination Tenofovir, Emtrisitabin and Evafirenz
Gilead Sciences, Inc. ID P0029476 Until the end of
patent period, 3
November 2024

 

The dark underbelly of India’s clinical trials business- #medical ethics #humanrights


Incidents at Bhopal and Indore highlight irregularities and ethical violations in some trials
Malia Politzer  |   Vidya Krishnan

First Published: Wed, Oct 10 2012. , at Live Mint

Protesters outside the Bhopal Memorial Hospital and Research Centre. Photo: Sayeed Farooqui/Mint
Updated: Thu, Oct 11 2012. 12 20 AM IST
New Delhi: In 2004, doctors at the Bhopal Memorial Hospital and Research Centre (BMHRC), established exclusively for treating the victims of the 1984 gas leak, recruited unsuspecting survivors for clinical trials without their knowledge or consent; 14 participants died during the course of the trials.
Together with the episode in Indore’s Maharaja Yashwantrao Hospital (that Mint reported on 10 October), where 32 people have died in clinical trials between 2005 and 2010, this incident highlights irregularities and ethical violations in some trials conducted by clinical research firms and pharma companies—the dark underbelly of the booming clinical trial business in India.
In 2005, India introduced patent protection laws. Since then, it has become a global hub for clinical trials, drawing companies because of its ethnically diverse pool of potential test subjects, while bringing down research and development (R&D) costs by nearly 60% in phase II and III trials, according to lobby group Confederation of Indian Industry.
A phase II trial establishes the protocol for testing and a phase III one is the final testing prior to approval.
Regulatory failures have marred the clinical trial business in India, experts said, pointing to lapses in the functioning of so-called ethical committees that are required by law for each trial, contract research organizations (CROs) and the Central Drug Standard Control Organization (CDSCO).
A parliamentary panel in May found CDSCO to be in collusion with drug companies and doctors, and approving at least one drug every month without conducting clinical trials or seeking expert medical opinion. Concerns over the conduct of clinical trials prompted the same panel to look into the rapidly growing industry, and the international and domestic pharmaceutical companies sponsoring them.

“Many issues have been raised in Parliament—people being treated as guinea pigs, lack of informed consent and unattributed deaths during trials,” said Sanjay Jaiswal, a Lok Sabha member and a physician himself. “We are not against clinical trials. The issue is about how these trials are being done. Rules need to be followed.”

A report on this will be presented to Parliament in the winter session, he said.
Medical ethicists are concerned that the rapid growth— without trained manpower or a clear-cut regulatory framework —could be a “race to the bottom”, with global ramifications and not just confined to one country.
“What the media doesn’t get straight is that drug companies aren’t using poor Indians as guinea pigs for Americans,” said Arthur Caplan, a bioethicist at the New York University Langone Medical Center. “The more common thing is that say Vietnam competes with India to see if the companies will come and bring in their studies, bring in the doctors, bring some relief if the drug or vaccine works—maybe spend some money in these places, give a bribe or two to the local health ministry to recruit in the local mental hospital. So, if India tightens regulation, companies will just go to Vietnam. This is not just an India problem—it’s a global issue.”
A globalized market
International boundaries blurred substantially when the US food and drug administration (FDA) relaxed regulations allowing drug companies to submit results of foreign trials in applications for new drugs to be marketed in the US.
Between 1990 and 2008, the number of clinical trials conducted largely by US companies shot up about 24 times to 6,465 from 271, according to a 2011 article in Vanity Fair. The 20 largest US-based drug makers conduct about one-third of their phase III clinical trials outside the country, and a majority of their study sites also are elsewhere, according to American Medical News.
A large genetic pool, high-quality hospitals, English-speaking staff and low costs make India an attractive destination for pharma firms looking to conduct clinical trials.
According to CDSCO, there are an estimated 150,000 people enrolled in clinical trials in India. According to a 2011 Associated Chambers of Commerce and Industry of India (Assocham) report, nearly 100 domestic and multinational pharmaceutical companies are conducting trials in the country and the business is worth Rs.8,000 crore.
Trials in countries such as India are cheaper to run: According to a 2008 Harvard Business Reviewarticle, tracking Indian test subjects costs between $1,500 and $2,000, (Rs.79,500 and Rs.1.06 lakh today), while in the US, it would cost $20,000.
When clinical trials are conducted ethically, India’s poor also stand to gain. With only 20% of India’s 1.2 billion people covered by health insurance and 35% living below the poverty line, the bulk of the population pays from the pocket for healthcare, according to health industry data provided by Assocham.
“A lot of patients don’t have access to healthcare otherwise,” said Irene Schipper, a researcher at the Netherlands-based Centre for Research on Multinational Corporations (SOMO). “But the problem, of course, is that when the clinical trial is over, they don’t have access anymore.”
Many clinical trials aren’t conducted ethically.
Schipper is concerned that tight regulatory policies in the US and the European Union (EU) appear to be driving high-risk trials to developing countries such as India, where rules or their enforcement may be lax. In 2008, SOMO released a report, Ethics for drug testing in low and middle-income countries, cataloguing a trend of offshoring risky clinical trials to developing countries that would be prohibited by ethics committees in the EU.
In one case, AstraZaneca Plc sponsored large, multi-centred placebo-controlled trials for Seroquel XR, an anti-psychotic drug for the treatment of patients with schizophrenia. The drug was tested against a placebo, which meant that roughly half the participants—all diagnosed schizophrenics—went without any treatment for the duration of the trial.
Due to the worsening of their conditions, 8.3% of the patients receiving the placebo required hospitalization. After 173 days of placebo treatment, one 25-year-old man committed suicide. “The consequences of this practice are serious,” Schipper said in the report. “According to the Declaration of Helsinki, this type of trial can never justify the use of a placebo because it involves withholding treatment from seriously ill patients risking irreversible harm. Nevertheless, the Dutch Medicines Evaluation Board approved Seroquel XR for the EU market.”
The multi-centre trials were conducted in India, Bulgaria, Poland, Russia and the Ukraine. While companies also continue to conduct such clinical trials elsewhere, “these days you’re seeing a lot more of these sorts of trials in India”, she said.
“At AstraZeneca, we take very seriously our responsibility towards the patients participating in our studies and our responsibility to deliver consistently high standards of ethical practice and scientific conduct in all our trials wherever they take place,” Andrew Higgins, a spokesperson for AstraZeneca, said in a statement.
“A placebo treatment does not imply a deficient standard of care. In accordance with the Good Clinical Practice rules, all patients in our clinical trials are provided with the same amount of care and are strictly monitored with the option to switch to another therapy or to be discontinued from the study where it becomes necessary,” he said.
Offshoring responsibility
Central to the growth of off-shoring clinical trials is the role of CROs—independent companies hired by sponsors to undertake clinical trials. Nearly 90% of trials in India are conducted by CROs, favoured by sponsors for their ability to form partnerships with local research organizations, recruit large numbers of participants and quickly conduct trials.
But medical ethicists worry this comes with a dark side. “To put it in a somewhat less polite way, the big company outsources the responsibility to the CRO. If something goes wrong, they say the CRO is completely responsible for this,” bioethicist Caplan said.
In 2011, CDSCO suspended the licence of Hyderabad-based CRO Axis Clinicals Ltd for recruiting illiterate women for a trial without obtaining proper consent. Following the incident, DCGI ordered an investigation into the operation of all 10 CROs in Andhra Pradesh.
Axis failed to respond to Mint’s repeated requests for comment.
“The problem with outsourcing to CROs is that oversight can be problematic,” said Schipper. Many CROs will divide tasks, such as administration, recruitment and research among various other CROs, making monitoring the process difficult for sponsors who are often based overseas, she said. “In our research, we’ve interviewed sponsors who have stopped using CROs entirely because they found that the cost of effectively monitoring them was greater than the money saved by hiring them.”
Caplan further worries that market incentives can drive CROs to complete trials at any cost. “There’s a conflict of interest when you hire a CRO, to act as a scientific and an ethical committee in India,” he said. “The sponsor wants the data—and wants it fast, and every day a study goes past its predicted date of completion, because they don’t have subjects enrolled, costs millions and millions of dollars—perhaps then they don’t continue to pay as much attention to informed consent or eligibility criteria.”
No functional regulatory system
Axis is not the first CRO in India to be facing hard questions: Quintiles, one of the largest global companies in the segment and based out of North Carolina, received a polite warning letter from DCGI for the clinical trials on Bhopal gas victims. “It should be noted that the studies conducted at BMHRC were approved by the Institutional Ethics Committee that was completely aware of the medical status of the patients visiting the hospital and participating in these trials,” Quintiles wrote in response to Mint’s inquiries.
Doctors, activists and researchers note that Indian ethics committees are often flawed. “Ethics committees are the front line regulators for clinical trials. If they were functional, they would be a major factor in preventing unethical trials,” said Amar Jasani, a researcher and trainer in the field of bioethics and public health. “The problem is the ethics committees are completely controlled by the institutions—they are not at all independent, the people on the committees are not trained, nor do they have the resources or independence to do their job.”
According to Jasani, Indian law allows for commercial ethics committees to be hired by the very CROs they are meant to monitor. “There’s a double conflict-of-interest,” he said. “They are governed by the CROs or the pharma companies. At the same time they are profit making—so they are more motivated by financial interest than (the safety of participants).”
While international standards governing clinical trials do exist, most are voluntary and lack regulatory teeth. The Delcaration of Helsinki, of which India is a signatory, says that potential research subjects need to be informed of the risks involved prior to participation, and reserve the right to refuse to participate.
Foreign drug authorities, such as FDA, have also made efforts to curtail unethical trials, by requiring that drug companies abide by certain guidelines. But their reach is limited. A 2010 report by the US Government Accountability Office found that FDA inspects fewer than 1% of clinical trials abroad, and that in many cases, it isn’t aware where clinical trials are being conducted until drug companies submit applications to market the new drug.
“There is no registry or international database—so I don’t think anyone knows what percentage of clinical trials are happening in the developing world. How many participants are men or women, old or young is also hard to know,” said Caplan. “We don’t have good information about what is really going on there, until there is a scandal, a problem or a death—but the overall picture is tough to know, because no one is responsible for monitoring it.”
The impact, though, is widespread: Nearly 80% of drug applications to FDA for marketing approval include tests done on foreign soil. With an FDA stamp of approval, many of the drugs end up being sold all over the world. “Seeing this as Americans exploiting Indians is not accurate,” said Caplan. “Drug companies are equally happy to sell to wealthy Indians. Drugs tested in these trials are eventually sold everywhere—studies in poor nations affect everyone.”

 

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