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Healthy Skepticism International News

July 2006

The worst kind of deceit: Fraud by Novartis and Max Foundation targets patients

The following is the English translation of the feature article by Silvia Garcia “El Peor de los Engaños: Fraude del laboratorio Novartis y la Fundación Max a pacientes” published in the magazine El Medico (No. 191, 30 July 2006) of Buenos Aires, accessed at: http://www.revistaelmedico.com.ar/rm/notas/vernota.php?id=1120

Translated by Chechi Vilasetru and Marta Vigués

Buenos Aires, Argentina

Abstract

There are no limits to the schemes used by pharmaceutical companies to increase their profits. A recent accusation submitted to the Argentine courts charges both Max Foundation and Novartis of ‘abusive, unlawful practices’. Both are accused of ‘acting in connivance (…) through different deceptive actions against leukemia patients and their families, such as persuasion and payment of attorneys’ fees to file lawsuits against health care organizations that are not providing them [the patients] with a certain medication (Glivec) or “using patients as a means to an end”. The plan would aim at positioning a product, Glivec, in the market.’

The worst kind of deceit: Fraud by Novartis and Max Foundation targets patients

By Silvia García

Max Foundation is a non-profit organization for patients with leukemia or other blood-related diseases. Its aim is to ensure better health conditions for leukemia patients all over the world, as well as improve their quality of life, though access to medication and technology. Priority is given to patients with ‘limited economic and medical care access’.

Such a mission would hardly seem to indicate anything illegal. But, as usual with any money-making activity—and unfortunately cancer patients are an easy target for such actions—this is no exception.

The Max Foundation was created in Seattle (US) in 1997, at the initiative of Argentine native Pedro Rivarola, father of Maximiliano, who died of chronic myeloid leukemia (CML) at the age of 17.

Like many in his situation, Rivarola was motivated by his personal tragedy to do something to help other patients. In 2001, a good opportunity to do so seemed to appear: Novartis Laboratories chose his foundation to carry out a [donation] program for low-income patients who were unable to afford the STI 571 Program, a research program that would lead to Glivec, a medication for CML patients. (STI 571 was the identifier for the drug during its pre-approval research phase). This initiative would become international under the name GIPAP (Glivec International Patient Assistance Program).

The research studies with Glivec demonstrated excellent results, to the extent that it was considered a real medical breakthrough, almost a wonder drug. The drug works by interfering with the growth of abnormal cancer cells caused by the disease, thus eliminating the use of chemotherapy, Alpha Interferon and even an eventual bone marrow transplant.

According to the research findings, patients need a daily dose of from four to eight capsules of Glivec Imatinib, depending on the extent of their disease. However, its price put it out of reach for low-income people, since treatment with doses of 400 mg a day came to US$ 30,000 a year.

So, while real-life CML patients couldn’t possibly pay this kind of price, speculators who had invested in the brand new product rejoiced over the thought of their future earnings.

 

Argentina’s self-made style…

This situation opened new horizons for the cure of the disease and the Max Foundation would also have its role to play. It also marked the beginning of a ‘fraudulent scheme’ which ended up in a lawsuit against the Max Foundation and world-reknowned Novartis Laboratories.

The legal charges were filed this past April by Zulma Pilar Labraña, a former Max Foundation employee in Argentina. After some deliberations, lawsuit number 66/06 was placed on the docket of the Juzgado Penal Económico No. 6, and assigned to the court of Judge Marcelo Aguinsky.

According to this claim, ‘Novartis Argentina S.A. implemented the GIPAP program in our country in ‘the Argentine way’, that is to say, as an aggressive sales plan for Glivec, disguised as a social plan, which included bribes (kickbacks).’

The claim describes the following: ‘The Program consisted of Novartis entrusting the Max Foundation with the administration of the assistance plan and the provision of Glivec to CML patients’. Max Foundation was in charge of the plan’s management: it selected institutions, doctors, and patients to be treated with Glivec. The Foundation was also to handle the whole management & logistic process, medication delivery and follow-up process. It also determined suitable locations around the world to extend the GIPAP Assistance Project.’  The claim also sustains that ‘to such effect, Novartis International donated US$ 400,000 to the Foundation’ (in 2001, the first half-year of operation). 

The claim explains that the operation was carried out ‘through various deceptive practices aimed at patients and their relatives, such as persuasion [to file lawsuits] and [giving them money for] payment to attorneys to file the appeals and lawsuits against the health care organizations who did not provide the product and also it manipulated patients to act as the intermediaries, organized [them to perform] community service projects for the Foundation and the Laboratories, and other social communication tasks’

Ms. Labraña contacted the Foundation in 2000, when she herself was diagnosed a condition similar to CML, and she started doing volunteer work for them. In 2001, she was hired as an employee. She was in charge of delivering Glivec donations and offering emotional support to patients. But at the end of 2002, Inés García Gonzáles de Arteaga, sister of the current Foundation’s president, Patricia García González, was put in charge of the Buenos Aires affiliate (of the Max Foundation). In other words, she started managing the GIPAP program directly for Novartis.

The next year, Labraña was fired via e-mail, due to alleged restructuring reasons [correction: her termination actually occurred in mid-2005].  Pedro Rivarola had also been removed [at that time] and his former wife, the same Patricia García González, replaced him as head of the Foundation in the U.S.

Labraña believes that it was her refusal to participate in the shady dealings of the foundation and its complicity with Novartis Argentina S.A.,that were the reason behind her dismissal. ‘I didn’t want to sign any appeals to force the government to supply Glivec, because I thought that it was dishonest for Novartis to be giving me money to hire a lawyer [for this purpose]’, she says.

 

The usual swindlers

This scheme is clearly described in the court documents: ‘The Program kept a 3-month reserve supply of Glivec for the patients. When the doses for the first phase of the treatment were delivered to the patients, including a 30 day supply to cover their immediate initial needs, the patients or their relatives were instructed to retain an attorney to start legal proceedings against the health care institutions which did not include Glivec in their formularies. After that, the provision of Glivec by the Foundation through their GIPAP Program was stopped. The investment by Novartis consisted of a single treatment [i.e. for one month] and then the company recovered its so-called donation by forcing the health care institutions to buy the product’.

In addition, the claim also details ‘other disloyal and illicit practices, such as the making of secret payments of bribes to doctors in order to position Glivec in Argentina, or the giving of gifts to oncologists’. An e-mail attached to the legal documents shows one of Novartis’ top executives blatantly warning a saleswoman: ‘I’d like you to tell me what were the criteria that you used to give out [as gifts] the previous forty jackets?  The idea is that each one of them [the jackets] represents a business deal for us. As I recall, we barely talked about any new deals with your doctors. Could you explain this to me?

Ms. Labraña perceives that, even though Novartis has its own charitable foundation, the connection with Max Foundation was made because they needed somebody unknown, somebody they could build up, a sort of ‘screen’ for the business’. ‘We could say that now, rather than a non-profit foundation it is a profit-making foundation. Its name is Novartis’ she remarked.

And in the first world, too

In June 2003, under the title ‘Novartis Glivec donation program falling short’ [sic], the prestigious American newspaper The New York Times published an article in which this ‘fraudulent maneuver’ by Novartis was anticipated.

What follows is an excerpt of the most important points included in that article.

‘In wealthier countries like South Korea, Hong Kong and New Zealand, Novartis, has encouraged patients who have received free drugs to become advocates, pressing public health systems to pay high prices for the drug. One company document declared that drug donations - along with media campaigns and legal tactics - were part of a concerted plan to win reimbursement for Glivec. ‘The term ‘patient assistance program’ is nothing but a marketing strategy’, said Dr. Arun Bal, a Bombay doctor.’
‘And in July, Dr. (David) Epstein (president of Novartis Oncology Division) sent a memo to company executives around the world proudly announcing that Novartis was establishing a drug donation program aimed at ensuring that no CML patient will be denied treatment with Glivec for financial reasons.’ He described the effort as ‘the most generous and far-reaching access program ever developed for a breakthrough cancer therapy’, adding that the intent was to help the company ‘achieve its therapeutic and business goals’ for the drug.’ A slide presentation prepared by Novartis a month earlier was more explicit in outlining the path to meeting the latter objective: ‘Max Patient Advocacy Work’, it said, would be directed at patients, physicians, media, legal pressure and community involvement, all with a single aim: to recover investment. With financing of US$ 1 million a year from Novartis, the Max Foundation rented an office, hired an administrative staff and began building a computer system that could handle the program, called the Glivec International Patient Assistance Program, or Gipap.’
‘By January 2002, objections from around the globe began appearing in online discussion groups dedicated to CML. Patients complained that eligibility requirements were out of step with the way doctors were prescribing the drugs. Some patients were getting the drug and others were not, for reasons not easily discerned.’
‘But once Glivec is approved, the company only supplies it only under a special program:  patients must then seek Glivec through private or government insurance and other conventional channels. But instead of becoming angry at Novartis, patients have protested to governments and have helped win victories for the company’.

 

 

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