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Hepatitis C: A Silent, Deadly Disease: Treatment Beyond Reach of Most Indians

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Every year, July 28 is remembered as the ‘World Hepatitis Day’. In India, this year too, the day had gone by virtually uneventful, for various reasons. This happened despite increasing trend of the disease in the country.

Though, there are five main hepatitis virus types, namely A, B, C, D and E, of which B and C are the most fatal, in this article, I shall focus mainly on hepatitis C.

According to the World Health Organization (WHO), globally around 150 million people are infected with chronic hepatitis C virus (HCV), which is considered as one of the key factors for liver cirrhosis, fibrosis and hepatocellular carcinoma. At least, 350,000 HCV infected people die annually from these ailments.

A July 2014 study conducted by Metropolis Healthcare reportedly found that 17.97 percent of 78,102 samples studied in major cities of India such as, Mumbai, Delhi and Chennai, were infected with HCV and the patients belonged to the age group of 20 to 30 years. Out of 10,534 the tested sample in the age group of 0 to 10 years, 3,254 samples (30.89 percent) tested positive with HCV.

Institutes of Medicine (IOM) and the Department of Health and Human Services (HHS) of the United States consider hepatitis C infections a “silent epidemic,” as many patients infected with HCV are symptom free, without even leaving any hint to them that they are infected. The infected persons may feel healthy, even when serious liver damage is taking place, sometimes through decades.

All these patients are also potential carriers of HCV, risking rapid spread of the virus, as identification of the infected individuals for remedial measures continue to remain mostly eluding in India.

According to experts, around 80 percent of the HCV patients ultimately develop chronic hepatitis with serious liver damage, causing significant debility. With further progression of the disease, around 20 percent of these patients could develop fatal liver cirrhosis and 5 percent may fall victim of liver cancer.

A situation like this, is indeed a cause of yet another major worry in the healthcare space of India. Deadly hepatitis C crisis would likely to worsen much, if it does not receive healthcare focus of all stakeholders, sooner.

Traditional treatment regime:

There is no vaccine developed for HCV, as yet. HCV usually spreads through sharing of needles, syringes or other equipment to inject drugs, infected blood transfusion and tattooing, among others.

The standard treatment for HCV is interferon-based injections, which could make patients feel ill and give rise to flulike symptoms. Moreover, the treatment with interferon lasts from six months to a year and cures only 40 to 50 of HCV infected patients.

Now, chronic HCV treatment also includes a combination of three drugs – ribavirin (RBV), pegylated interferon (PEG) and a protease inhibitor, such as, simeprevir or boceprevir or telaprevir. These three drug combinations inhibit viral replication for enhancing immune response of the body to hopefully eradicate the virus.

At times, patients with very advanced liver disease may not be able to tolerate this traditional treatment with interferon-based injections, as those could make them feel worse.

The latest development in treatment:

There has been a significant advance in the treatment of HCV patients today with a new drug in the form of tablet that has doubled the viral cure rates from 40 to 50 percent to 90 to 100 percent.

Moreover, the new drug not just enables the physicians switching from injectibles to oral tablet, but at the same time reduces the duration of treatment to just 12 weeks, instead of 6 months to one year, offering a huge advantage to patients suffering from HCV.

This new generation of treatment now includes only Sovaldi (sofosbuvir) of Gilead, which is the first drug approved to treat certain types of hepatitis C infection, without any compelling need to co-administer with interferon.

Some other global pharma majors, such as Bristol-Myers Squibb, Merck & Co, Johnson & Johnson and AbbVie are also developing oral treatment regimens for HCV. All these have shown equally dramatic results in clinical trials, reducing the requirement for debilitating interferon injections.

Allegation of profiteering:

Looking at the high cure rate of more than 90 per cent for much-distressed HCV infected patients, none would possibly dispute that Sovaldi of Gilead signifies a giant leap in the treatment of HCV. But Gilead, according to a ‘Financial Times (FT)’ report, faces strong criticism of alleged ‘profiteering’ for its pricing strategy of this drug.

Sovaldi has been priced by Gilead at Rs 60,000 (US$ 1,000) per tablet with a three-month course costing Rs1.8 Crore (US$ 84,000), when it reportedly costs around U$130 to manufacture a tablet. This treatment cost is being considered very high for many Americans and Europeans too.

“At the US price, Gilead will recoup its Sovaldi development investment  . . . in a single year and then stand to make extraordinary profits off the backs of US consumers, who will subsidize the drug for other patients around the globe”, the FT report states.

This line of argument has been gaining ground on Capitol Hill, as well. This month, two senior members of the US Senate Finance Committee wrote to John Martin, Gilead Chief Executive, asking him to justify Sovaldi’s price, the report mentioned.

Half yearly sales of US$ 5.8 billion came from just 9,000 patients:

Be that as it may, the bottom line is, in the midst of huge global concerns over alleged ‘profiteering’ with this exorbitantly priced HCV drug, Gilead has reportedly registered US$ 5.8 billion in sales for Sovaldi in the first half of 2014.

The company has reportedly noted on its earnings call that it believes 9,000 people have been cured of HCV so far with Sovaldi. This means that the 6-month turnover of Sovaldi of US$ 5.8 billion has come just from 9000 patients. If we take the total number of HCV infected patients at 150 million globally, this new drug has benefited just a minuscule fraction of less than one percent of the total number of patients, despite clocking mind-boggling turnover and profit.

Stakeholders’ pressure building up:

Coming under intense pressure from all possible corners, Gilead has reportedly announced that it has set a minimum threshold price of US$ 300 a bottle, enough for a month. With three months typically required for a full course and taking into account the currently approved combination with interferon, the total cost per patient would be about US$ 900 for a complete treatment against its usual price of US$ 84,000. The company would offer that price to at least 80 countries.

For this special price, Gilead reportedly has targeted mostly the world’s poorest nations, but also included some middle income ones such as Egypt, which has by far the highest prevalence of HCV in the world. In Egypt, about 10 million people remain chronically infected and 100,000 new infections occur each year, according to Egyptian government figures. However, independent surveys  put this number between 200,000 and 300,000. Gilead has already signed an agreement with the Egyptian government in early July 2014 and the drug would be available there in September 2014. This would make Egypt the first to have access to Sovaldi outside the US and the EU.

What about India?

Gilead has reportedly announced, “In line with the company’s past approach to its HIV medicines, the company will also offer to license production of this new drug to a number of rival low-cost Indian generic drug companies. They will be offered manufacturing knowhow and allowed to source and competitively price the product at whatever level they choose.”

This is indeed a welcoming news for the country and needs to be encouraged for expeditious implementation with support and co-operation from all concerned.

Regulatory requirement:

However, despite all good intent, Gilead says, “ Some countries, such as India and China, are not satisfied with the tests conducted in the US and elsewhere for Sovaldi. They want additional clinical trials to be conducted on their own patients as a precondition for authorization, which will add extra costs and delays.”

Patent status:

It is worth noting here that the Indian patent office has not even recognized Sovaldi’s patent for the domestic market.

Local measures to address chronic hepatitis:

On May 22, 2014, the World Health Assembly adopted a resolution to improve prevention, diagnosis and treatment of viral hepatitis, in general. However, as things stand today in India, the surveillance systems for viral hepatitis are grossly inadequate and preventive measures are not universally implemented.

The Union Government of India has now expressed its intent to set up ten regional laboratories through the National Communicable Disease Centre (NCDC) for surveillance of viral hepatitis in the country. The key objective of these laboratories would be to ascertain the burden of viral hepatitis in India by 2017 and to provide lab support for investigating outbreaks.

Government sources indicate, the initial focus would be more on the preventive aspects rather than treatment of viral hepatitis given the limited health resources available. Setting up universal guidelines for immunization along with mass awareness and education have been considered as critical to fight this dreaded disease in the country. Simultaneously introduction of nucleic acid testing (NAT) and standardization of blood bank practices would be undertaken for preventing blood transfusions related viral hepatitis, in general.

Treatment for HCV is not widely available in the country. All types of HCV treatments, especially the newer and innovative ones, must be made available to all infected patients, as these drugs have high cure rates, short duration of treatment and minimal side effects.

Conclusion:

Viral hepatitis in general and hepatitis C in particular are becoming great national health concerns, as these contribute to significant morbidity and mortality, further adding to the national economic burden. India should just not strengthen its prevention strategies; it needs to focus on all the factors that influence speedy diagnosis and treatment of HCV.

As the WHO says, “New drugs have the potential to transform hepatitis C treatment, with safe and simple treatments resulting in cure rates of over 90 per cent”. The raging debate on Sovaldi needs to explore the newer avenues and measures for appropriately pricing the innovative medicines in the days ahead.

Concerned pharma players, the government and other stakeholders must work together and in unison to ensure that all those infected with HCV are diagnosed quickly and have access to life-saving treatments.

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Big Pharma Receives Another Body Blow: Would Indian Slumber End Now?

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On May 13, 2014, The New York Times reported, while major pharmaceutical companies have been facing increased scrutiny of their marketing practices from governments around the world, last Wednesday the Chinese authorities sent a strong warning to the pharmaceutical industry implicating Mark Reilly, the former head of Glaxo’s China operations, of ordering his subordinates to form a “massive bribery network” that resulted in higher drug prices and illegal revenue of more than US$150 million.  Mr. Reilly, a Briton, and two Chinese-born Glaxo executives, Zhang Guowei and Zhao Hongyan, had allegedly arranged to bribe government officials in Beijing and Shanghai.

The Chinese police has reportedly said that its 10-month investigation has found that under Mr. Reilly, Glaxo had pushed its staff to meet aggressive sales targets and that the company had conducted “false transactions” through its financial department to transfer “illegal gains” made in China to overseas companies. The authorities also said Mr. Reilly and other senior executives at Glaxo had bribed officials to stop investigations of wrongdoing at the company.

The report also states, although bribery is common in China, it is rare for foreign-born executives from MNCs to be prosecuted. In 2009, a Chinese-born Australian executive at the British-Australian mining giant Rio Tinto was arrested in a bribery and money-laundering case.

“Ethics Matter” – A Chinese warning to MNCs:

On May 16, 2014, Xinhua – the official news agency of China wrote in an editorial that Chinese probe into GSK’s local sales practices should send a warning to other foreign companies doing business in the country that “Ethics Matter”.

This stern action by China is indeed another body blow on the so called ‘ethical image’ of Big Pharma, despite its sophisticated global ‘Public Relations’ machinery working overtime under the respective pharma associations across the world.

Drug price manipulation:

While citing the example of a hepatitis B drug – Heptodin, Xinhua editorial said that GSK “manipulated prices to disguise real costs”, as Heptodin is declared as 73 Yuan to customs in China even though the actual cost is 15.7 Yuan and is sold at 26 Yuan in Canada or 30 Yuan in the U.K.

Quoting a Ministry of Public Security official at a briefing on May 14, it stated that Glaxo charged prices in China that in some cases were seven times as high as in other countries, and used the extra money to pay bribes.

According to this media report, in June last year, “Chinese authorities began investigating allegations that Glaxo had funneled money through local travel agencies to pay bribes to doctors in return for prescribing its drugs. They last year detained some executives on suspicion of economic crimes involving 3 billion Yuan of spurious expenses and trading in sexual favors.”

Not a first time allegation:

This is not the first of such cases and most probably won’t be the last also. Since quite some time many pharmaceutical giants are being reportedly investigated and fined, including out of court settlements, for bribery charges related to the physicians.

In this context July 4, 2012, edition of The Guardian reported a similar astonishing story on Big Pharma. When you click on this short video clipping, which was published on September 29, 2012 you would see that Big Pharma’s Medicaid fraud penalties had reached a record high with GlaxoSmithKline fined $3 Billion in the United States at that time.

It is widespread:

Following are a few more recent examples to help fathom the enormity of the problem:

  • In March 2014, the antitrust regulator of Italy reportedly fined two Swiss drug majors, Novartis and Roche 182.5 million euros (U$ 251 million) for allegedly blocking distribution of Roche’s Avastin cancer drug in favor of a more expensive drug Lucentis that the two companies market jointly for an eye disorder.
  • Just before this, in the same month of March 2014, it was reported that a German court had fined 28 million euro (US$ 39 million) to the French pharma major Sanofi and convicted two of its former employees on bribery charges.
  • In November 2013, Teva Pharmaceutical reportedly said that an internal investigation turned up suspect practices in countries ranging from Latin America to Russia.
  • In May 2013, Sanofi was reportedly fined US$ 52.8 Million by the French competition regulator for trying to limit sales of generic versions of the company’s Plavix.
  • In August 2012, Pfizer Inc. was reportedly fined US$ 60.2 million by the US Securities and Exchange Commission to settle a federal investigation on alleged bribing of overseas doctors and other health officials to prescribe medicines.
  • In April 2012, a judge in Arkansas, US, reportedly fined Johnson & Johnson and a subsidiary more than US$1.2 billion after a jury found that the companies had minimized or concealed the dangers associated with an antipsychotic drug.

There are many more of such examples.

The situation is alarming in India too:

Back home in India, deep anguish of the stakeholders over this issue is now being increasingly reverberated on every passing day, as it were. It has also drawn the attention of the patients’ groups, NGOs, media, Government, Planning Commission and even the Parliament.

An article titled, “Healthcare industry is a rip-off” published in a leading daily, the author highlighted that the absence of regulatory oversight in the healthcare industry needs urgent attention.

The quality of the pharmaceutical marketing in India has touched a new low, causing suffering to patients. Unethical drug promotion is increasingly becoming an emerging threat to society. The Government provides few checks and balances on drug promotion.

To counter the problem of ‘Unethical Drug Promotion’ to a great extent, the author broadly recommended the following:

  • Preparing treatment guidelines,
  • Conducting periodic prescription audits,
  • Generating consumer awareness and empowering consumer with relevant information in an user friendly way
  • Regulating entertainment of doctors in the garb of Continuing Medical Education (CME)

Moreover, the Department Related Parliamentary Standing Committee on Health and Family Welfare in its 58th Report strongly indicted the Department of Pharmaceuticals (DoP) on this score. It observed that the DoP should take prompt action in making the ‘Uniform Code of Pharmaceutical Marketing Practices (UCPMP)’ mandatory so that effective checks and balances could be brought-in on ‘huge promotional costs and the resultant add-on impact on medicine prices’.

Even the Planning Commission of India has reportedly recommended strong measures against pharmaceutical marketing malpractices as follows:

“Pharmaceutical marketing and aggressive promotion also contributes to irrational use. There is a need for a mandatory code for identifying and penalizing unethical promotion on the part of pharma companies. Disclosure by pharmaceutical companies of the expenditure incurred on drug promotion to be made mandatory, ghost writing in promotion of pharma products to attract disqualification of the author as well as penalty on the company, and vetting of drug related material in Continuing Medical Education (CME) should be considered.”

Unfortunately, nothing substantive has been done in India to effectively address such malpractices in a comprehensive manner, as yet, to protect patients’ interest.

A pending PIL:

Despite deplorable inaction by the government on the subject, frequent reporting by Indian media has triggered a national debate on this issue. A related Public Interest Litigation (PIL) is also now pending before the Supreme Court for hearing in the near future. Its judicial verdict is expected to usher in a breath of fresh air around a rather stifling environment for the patients.

Ethical marketing conduct in India – A Survey:

A survey report of Ernst and Young titled, “Pharmaceutical marketing: ethical and responsible conduct”, carried out in September 2011 on the UCMP and MCI guidelines, highlighted the following:

  • Two-third of the respondents felt that the implementation of the UCPMP would change the manner in which pharma products are currently marketed in India.
  • More than 50 percent of the respondents are of the opinion that the UCPMP may lead to manipulation in recording of actual sampling activity.
  • Over 50 percent of the respondents indicated that the effectiveness of the code would be very low in the absence of legislative support provided to the UCPMP committee.
  • 90 percent of the respondents felt that pharma companies in India should focus on building a robust internal controls system to ensure compliance with the UCPMP.
  • 72 percent of the respondents felt that the MCI is not stringently enforcing its medical ethics guidelines for the doctors.
  • 36 percent of the respondents felt that the MCI’s guidelines could have an impact on the overall sales of pharma companies.

 Conclusion:

Increasingly many companies across the world are reportedly being forced to pay heavily for ‘unethical behavior and business practices’ by the respective governments.

Intense quarterly pressure for expected business performance by stock markets and shareholders could apparently be the trigger-points for short changing such codes and values.

Be that as it may, I reckon, the need to announce and implement the UCPMP by the Department of Pharmaceutical under the new Modi Government, assumes critical importance in today’s chaotic pharmaceutical marketing scenario. At the same time, demonstrable qualitative changes in corporate ethics and value standards in this regard should always be important goals for any pharmaceutical business corporation in India.

Though late, China has at least started cracking down on the perpetrators of this alleged crime. As corruption conscious Modi-Government assumes office in the country, would India wake-up now to stop this growing menace by enacting and then strictly enforcing the rule of law?

By: Tapan J Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.