Two Paintings on the Same Canvas: ‘Truth About Drug Companies’ and ‘Protecting Access to Medicines’

As the saying goes, “Great people think alike”, many thought leaders of very high credibility across the globe, seem to think almost in similar lines when it comes to improving access to medicines for a large section of the global population.

In this article, I shall briefly focus on two such instances, both revolving around the same centerpiece – one from India and the other from the land of ‘pharmaceutical innovation’ – America.

An interesting article written recently by the well-regarded Indian expert of global stature Dr. K. Srinath Reddy, President, Public Health Foundation of India (PHFI), reiterates emphatically,  “India must protect access to medicine”.

In a more focused context related to EU-FTA, the author wrote about possible adverse impact of more stringent product patent and regulatory data protection related issues on access to generic medicines in India and other developing countries. Thus, he argued that EU-FTA should be well negotiated by India and cautioned as  follows:

“It must be remembered that India needs to protect its vital interests in any trade agreement, just as other nations strive to. Our interest lies in protecting the lives and safeguarding the health of Indians, without permitting unreasonable restrictions on our ability to produce, use and even export, generic versions of drugs the patents of which have lapsed (or where compulsory licensing has been invoked to protect public health).

India needs to tread carefully while negotiating the FTA with the EU, so that the health of the Indian people is not compromised through provisions that shackle our generic drug industry.

The debate has assumed a global dimension:

Such raging debates on a critical public health issue, like access to medicines, are also taking place in many other countries, as I write, including America, irrespective of the fact whether these are generic or patented drugs.

Marcia Angell, M.D, a faculty of Harvard Medical School and a former Editor in Chief of the world’s leading medical journal ‘The New England Journal of Medicine’ wrote an interesting book.

In this book titled “The Truth About the Drug Companies: ‪How They Deceive Us and What to Do About It”, she makes many interesting comments on the American pharmaceutical industry on access to medicines and the kind of pharmaceutical innovations that they are involved in.

The world noticed it:

This book arrested global attention and was extensively reviewed. Since, the author wrote more specifically about the American pharmaceutical industry, following are some excerpts quoted from her book reviews in the USA:

New York Times: “A scorching indictment of drug companies and their research and business practices…tough, persuasive and troubling.”

Boston Globe: “A sober, clear-eyed attack on the excesses of Drug Company power…a lucid, persuasive, and highly important book.”

Washington Post: “Always authoritative…[this book] delivers the message—that drug-company money and power is corrupting American medicine—in a convincing, no-nonsense manner.”

Some key issues raised in the book:

Like the above article of Dr. Reddy, here also the author raises some interesting issues related to the American drug companies. I am penning below some of those issues exactly as expressed by the author (verbatim):

  • The magic words, repeated over and over like an incantation, are research, innovation, and American. Research. Innovation. American. It makes a great story.
  • “R&D is a relatively small part of the budgets of the big drug companies—dwarfed by their vast expenditures on marketing and administration, and smaller even than profits.”
  • The great majority of ‘new’ drugs are not new at all but merely variations of older drugs already on the market. These are called ‘me-too’ drugs.”
  • “If I’m a manufacturer and I can change one molecule and get another twenty years of patent rights, and convince physicians to prescribe and consumers to demand the next form of Prilosec, or weekly Prozac instead of daily Prozac, just as my patent expires, then why would I be spending money on a lot less certain endeavor, which is looking for brand-new drugs?”
  • “Over the past two decades the pharmaceutical industry has moved very far from its original high purpose of discovering and producing useful new drugs. Now primarily a marketing machine to sell drugs of dubious benefit, this industry uses its wealth and power to co-opt every institution that might stand in its way, including the US Congress, the FDA, academic medical centers, and the medical profession itself. (Most of its marketing efforts are focused on influencing doctors, since they must write the prescriptions.)”
  • “Now universities, where most NIH-sponsored work is carried out, can patent and license their discoveries, and charge royalties. Similar legislation permitted the NIH itself to enter into deals with drug companies that would directly transfer NIH discoveries to industry.”
  • “Many medical schools and teaching hospitals set up “technology transfer” offices to help in this activity and capitalize on faculty discoveries. As the entrepreneurial spirit grew during the 1990s, medical school faculty entered into other lucrative financial arrangements with drug companies, as did their parent institutions.”
  • “One of the results has been a growing pro-industry bias in medical researchexactly where such bias doesn’t belong.”
  • “In the 1990s, Congress enacted other laws that further increased the patent life of brand-name drugs. Drug companies now employ small armies of lawyers to milk these laws for all they’re worth—and they’re worth a lot. The result is that the effective patent life of brand-name drugs increased from about eight years in 1980 to about fourteen years in 2000.”
  • “The biggest single item in the budget is neither R&D nor even profits but something usually called ‘marketing and administration – a name that varies slightly from company to company.”
  • The industry is fighting these efforts—mainly with its legions of lobbyists and lawyers. It fought the state of Maine all the way to the US Supreme Court, which in 2003 upheld Maine’s right to bargain with drug companies for lower prices, while leaving open the details. But that war has just begun, and it promises to go on for years and get very ugly.”
  • “The fact that Americans pay much more for prescription drugs than Europeans and Canadians is now widely known.”
  • “There are very few drugs in the pipeline ready to take the place of blockbusters going off patent. In fact, that is the biggest problem facing the industry today, and its darkest secret. All the public relations about innovation is meant to obscure precisely this fact.”
  • “Of the 78 drugs approved by the FDA in 2002, only 17 contained new active ingredients, and only seven of these were classified by the FDA as improvements over older drugs.”
  • “While there is no doubt that genetic discoveries will lead to treatments, the fact remains that it will probably be years before the basic research pays off with new drugs. In the meantime, the once-solid foundations of the big pharma colossus are shaking.”
  • “Clearly, the pharmaceutical industry is due for fundamental reform. Reform will have to extend beyond the industry to the agencies and institutions it has co-opted, including the FDA and the medical profession and its teaching centers.”
  • The me-too market would collapse virtually overnight if the FDA made approval of new drugs contingent on their being better in some important way than older drugs already on the market.”
  • A second important reform would be to require drug companies to open their books. Drug companies reveal very little about the most crucial aspects of their business.
  • “But the one thing legislators need more than campaign contributions is votes. That is why citizens should know what is really going on. Contrary to the industry’s public relations, they don’t get what they pay for. The fact is that this industry is taking us for a ride, and there will be no real reform without an aroused and determined public to make it happen.”

An opposite view:

On this an article in Forbes Magazine commented as follows:

“The problem with Angell’s arguments is that they are rife with inaccuracies and fallacies. Furthermore, she makes no accounting for changes in the industry that have occurred over the last decade.”

“It is time for those in the medical profession to spur a more truthful and factual discussion about the pharmaceutical industry and its role in the discovery and development of new medicines. The pharmaceutical industry is a key player in the evolution of healthcare and this needs to be recognized if the industry is to operate effectively.”

Conclusion:

One of the key counter arguments that very often comes up in this area, including in India is, the protection of Intellectual Property Rights (IPR) is the responsibility of the Government concerned at any cost, even if such protective measures severely restrict access to these drugs to a large population of the society across the globe, due to ‘affordability’ considerations.

It is also claimed that, to come out with innovative medicines, large pharmaceutical companies invest a huge amount of money and time towards R&D related activities.

Thus, the global innovator companies, by and large, with a few exceptions though, believe that stricter enforcement of stringent patent laws by the Governments is the only answer to foster innovation within the industry. Such stringent measures, as they argue, will help them keep investing in R&D to meet the ‘unmet needs’ of patients on a continuous basis.

However, as we have seen above, many experts, like Harvard faculty Marcia Angell and Dr. K. Srinath Reddy have strong and quite different view points. It is certain that the debate on access to affordable medicines is not going to die down, at least any time soon.

Despite all these, it is not difficult, I reckon, to identify an emerging but a clear trend indicating, the priority of the Governments to protect public health interest in the longer term, will ultimately prevail in most parts of the world, including India.

Consequently, the world will probably witness more and more new government policies and legal frameworks in this area striking a right balance between improving access to medicines and fostering innovation, as the countries move on.

That said, taking note of the above two paintings, as it were, painted on the same canvas of ‘improving access to medicines for all’, is it not amazing to note a striking similarity in the thought pattern between two highly credible and independent think tanks, belonging to the oldest and largest democracies of the planet earth, to ensure affordable medicines for all?

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.

“Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients”: Exploring the book to be released in the Indian context

The title of today’s article could make some of the readers uncomfortable and angry, just as what I experienced while writing the same, being a long time follower and student of the pharmaceutical industry, both global and local.

Ethical business conduct and value standards, especially of medium, large to very large pharmaceutical corporations both in India and across the world are coming increasingly under stakeholders’ scrutiny, besides being severely criticized for non-compliance in many instances by the regulators, judiciary and public at large. We shall find many such examples over a long period of time even from within our own land.

There is no global consensus, as yet, on what is ethically and morally acceptable ‘Business Ethics and Values’ across the world, although there are some very strong common parameters that can be globally followed.

In many companies’ websites such standards are also available in their minutest details. Unfortunately, even some of those companies are also being reportedly held guilty for blatant violations of their own set standards of ethics and compliance.

This trend could prompt one to believe, sincere attempts are still lacking to ensure effective implementation of such well drafted ‘Business Ethics and Values’ in country-specific ways by many of these companies.

The most challenging obstacle to overcome in this area by the corporates, I reckon, would still remain ‘walking the talk’, owning the responsibility and taking sustainable remedial measures, at least when these violations are conclusively established followed by penal actions.

A new book with graphic details: 

In this context, ‘The Economist’ in its September 29, 2012 reviewed a book titled ‘Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients’, written by Ben Goldacre, a British doctor and science writer. According to Amazon the book is due to be released on January 8, 2013.

In this book the author describes incidences of routine corruption in the healthcare system and brings out to the fore citing details of some of the following areas, how patients’ interests are being continuously and blatantly compromised by many pharmaceutical companies unabated, just for commercial gain:

  1. Pharmaceutical companies bury clinical trials which show bad results for a drug and publish only those that show a benefit.
  2. The trials are often run on small numbers of unrepresentative patients, and the statistical analyses are massaged to give as rosy a picture as possible.
  3. Entire clinical trials are run not as trials at all, but as ‘under-the-counter advertising campaigns’ designed to persuade doctors to prescribe a company’s drug.

Dr. Ben Goldacre does not spare the drug regulators also as he writes, ‘drug regulators, who do get access to some of the hidden results, often guard them jealously, even from academic researchers, seeming to serve the interests of the firms whose products they are supposed to police.’

The author also writes that ‘many studies published in reputed medical journals are written by the commercial ghostwriters, who are paid by the pharmaceutical companies and are not written by those whose names appear as the author of those studies. He laments that based on such clinical trial reports blitzkrieg expensive marketing campaigns are conducted to influence doctors prescribing such drugs.

None of the above instances is unreported in India, may be in forms which are many shades worse than what has been described by Dr. Ben Goldacre in his above book.

‘The Economist’ recommends that ‘this is a book that deserves to be widely read, because anyone who does read it cannot help feeling both uncomfortable and angry’.

India can’t delay tightening its belt any further:

The concerns of Dr. Ben Goldacre are also being expressed in India quite vocally, almost in all the areas as mentioned above. Thus India needs to tighten its regulatory systems and ensure proper implementation of all its policies, and if required framing some new ones, so that the country can come out of this quagmire which severely hurts the patients’ interests at large.

Among many others, two critical areas where such alleged corporate malpractices are being continuously reported are as follows:

I. Clinical Trials

II. Marketing Practices 

I. Ethical concerns over Clinical Trial in India are not getting mitigated:

Clinical trial system still remains a critical area of concern in India. The Bulletin of the World Health Organization (WHO) in an article titled, “Clinical trials in India: ethical concerns” reported as follows:

“Drug companies are drawn to India for several reasons, including a technically competent workforce, patient availability, low costs and a friendly drug-control system. While good news for India’s economy, the booming clinical trial industry is raising concerns because of a lack of regulation of private trials and the uneven application of requirements for informed consent and proper ethics review.”

Because of this reason, on October 8, 2012 the Supreme Court reportedly asked the government to provide details of clinical trials being conducted across the country, which will include drug side effects and clinical trial related deaths, in which case compensation, if any, paid to the victims or to their family members.

This direction came from the apex court of the country while hearing a Public Interest Litigation (PIL) alleging Indian citizens are being used as guinea pigs during clinical trials by the pharmaceutical companies all over the country, mainly due to lack of informed consent of the enrolled patients and thereafter short changing their interest citing various reasons.

Clinical-trials process of the country is now, therefore, under intense scrutiny of the government, NGOs and also of the judiciary after a number of scandals focusing on malpractices, somewhat similar to what Dr. Ben Goldacre has highlighted in his book, as mentioned above. These series of events have recently prompted the regulators to come out with proposals of reforms in this important area, for all concerned.

The Parliament intervened:

Recently the department related ‘Parliamentary Standing Committee (PSC)’ on Health and Family Welfare presented its 59th Report on the functioning of the Indian Drug Regulator – the Central Drugs Standard Control Organization (CDSCO) in both the houses of the Parliament on May 08, 2012.

The PSC in its report made, the following critical findings, besides others:

  • “A total of 31 new drugs were approved in the period January 2008 to October 2010 without conducting clinical trials on Indian patients.
  • Thirteen drugs scrutinized by the panel are not allowed to be sold in the United States, Canada, Britain, European Union and Australia.
  • Sufficient evidence is available on record to conclude that there is collusive nexus between drug manufacturers, some functionaries of CDSCO and some medical experts.
  • Due to the sensitive nature of clinical trials in which foreign companies are involved in a big way and a wide spectrum of ethical issues and legal angles, different aspects of clinical trials need a thorough and in-depth review.”

Regulators woke-up:

In response to the prevailing conundrum, ‘The Ministry of Health and Family Welfare’ of the Government of India issued a draft notification on 17th July, 2012 seeking stakeholders’ views on the ‘Permission to conduct Clinical Trial’.

The draft notification says that the licensing authority only after being satisfied with the adequacy of the data submitted by the applicant in support of proposed clinical trial, shall issue permission to conduct clinical trial, subject to compliance of specified stringent conditions.

However, some experts do apprehend that such stringent system could give rise to significant escalation in the costs of clinical trials for the pharmaceutical players.

Similarly to assess right compensation for clinical trial related injuries or deaths following parameters were mooted in the document:

  • Age of the deceased
  • Income of the deceased
  • Seriousness and severity of the disease, the subject was suffering at the time of his/her participation into the trial.
  • Percentage of permanent disability.

 II. Ethical concerns on marketing malpractices in India: 

This issue has no longer remained a global concern. Frequent reports by Indian media have already triggered a raging debate in the country on the subject, involving even the Government and also the Parliament. It has been reported that a related case is now pending with the Supreme Court for hearing in not too distant future.

In 2010, ‘The Parliamentary Standing Committee on Health’ expressed its deep concern that “the evil practice” of inducement of doctors continued because the Medical Council of India (MCI) had no jurisdiction over the pharma industry and it could not enforce the code of ethics on it.’

It was widely reported that the letter of the Congress Member of Parliament, Dr. Jyoti Mirdha to the Prime Minister Dr. Manmohan Singh, attaching a bunch of photocopies of the air tickets to claim that ‘doctors and their families were beating the scorching Indian summer with a trip to England and Scotland, courtesy a pharmaceutical company’, compelled the Prime Minister’s Office (PMO) to initiate inquiry and action on the subject.

The letter had claimed that as many as 30 family members of 11 doctors from all over India enjoyed the hospitality of the pharmaceutical company.

In addition Dr. Mirdha reportedly wrote to the PMO that “The malpractice did not come to an end because while medical profession (recipients of incentives) is subjected to a mandatory code, there is no corresponding obligation on the part of the healthcare industry (givers of incentives). Result: Ingenious methods have been found to flout the code.”

The report also indicated at that time that the Department of Pharmaceuticals (DoP) is trying to involve the Department of Revenue under the Ministry of Finance to explore the possibilities in devising methods to link the money trail to offending companies and deny the tax incentives.

Incidences of such alleged malpractices related to financial relationship between the pharmaceutical companies and the medical profession are unfolding reasonably faster now. All these issues are getting increasingly dragged into the public debate where government can no longer play the role of a mere bystander.

Taking the first step closer to that direction, Central Board of Direct Taxes (CBDT), which is a part of Department of Revenue in the Ministry of Finance has now decided to disallow expenses on all ‘freebies’ to Doctors by the Pharmaceutical Companies in India.

A circular dated August 1, 2012 of the CBDT that the any expenses incurred by the pharmaceutical companies on gifts and other ‘freebies’ given to the doctors will no longer be allowed as business expenses. 

Conclusion:

Statistics of compliance to ‘The Codes of Business Ethics & Corporate Values’ are important to know, but demonstrable qualitative changes in the ethics and value standards of an organization should always be the most important goal to drive any business corporation, the pharmaceutical industry being no exception.

The need to formulate ‘Codes of Business Ethics & Values’ and even more importantly their compliance are gradually gaining importance and relevance in the globalized business environment.

However, quite in conflict with the above initiative, at the same time, many pharmaceutical corporations across the world are being increasingly forced to come to terms with the heavy costs and consequences of ‘unethical behavior and business practices’ by the respective governments and judiciary. Unfortunately the Juggernaut still keeps moving, perhaps arising out of intense pressure for corporate business performance.

I am not quite sure though, whether such an expectation for ‘Corporate Ethics and Values’ is ‘utopian’ for the pharmaceutical industry or can be translated into reality with some amount of sincere efforts and commitment. However, if it does not happen, sooner than later, the ‘Bad Pharma’ image of the pharmaceutical industry across the world, as enunciated by Dr. Ben Goldacre in his book, will continue to linger inviting increasingly fierce public wrath along with stringent government regulatory controls and judicial interventions.

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.