Tag Archives: JAMA

Is The Department of Pharmaceuticals On The Same Page As The Prime Minister?

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“The open secret is that pharmaceutical companies throw all manners of inducements on doctors to prescribe their medicines. The victim of their misdemeanors is the unsuspecting patient. Mr. Modi clearly wants to break this self-serving chain” – highlighted a media report on April 20, 2017.

“Prime Minister Modi wants to end the unholy doctor-drug industry nexus” – echoed another media headline on the same day.

In a step towards this direction for the benefits of patients, the PM hinted at making prescriptions in generic names of drugs mandatory through a legal framework. There could be many challenges ahead to achieve this objective, but the fact remains just the same. A study published in a well-acclaimed medical journal, even after the PM’s much talked about pledge, re-establishes the adverse impact of this alleged nexus through a bioequivalarge research study.

In this article, I shall not go into the details of what the PM had said in this regard and the impact of the same on patients, pharma companies, different types of service providers to the branded-generic business, and the Indian Pharma Market (IPM), as I have already done that. Neither shall I focus here on the action expected from the Union Ministry of Health, as they have, at least, amended the statute making the bioequivalence studies mandatory, though several other action steps need to follow. Today, I shall deliberate only on one question: Is the department of pharma on the same page with the PM on effectively addressing the alleged ‘doctor-drug industry nexus’?

A recent study:

The following very recent study elegantly highlighted the criticality of snapping this unholy link, as many believe, for the patients’ sake.

The May 2, 2017 JAMA editorial titled, “Reconsidering Physician – Pharmaceutical Industry Relationships” articulated, physicians need to balance the risk and benefits of treatments, especially when inputs come from companies whose interests may conflict directly with those of patients. Drug costs, though revenue to their respective manufacturers, are high out of pocket expenditure to patients, many of whom seriously struggle to afford their medical treatment.

The above editorial comment was based on an ‘Original Investigation’ study titled, “Association Between Academic Medical Center Pharmaceutical Detailing Policies and Physician Prescribing”, published on the same day in the same esteemed journal.

This large study was aimed at measuring the outcome of an effort by some Academic Medical Centers (AMCs) in the United States to regulate physicians’ conflict of interest in this area. These AMCs enacted policies restricting pharmaceutical representatives’ visits to physicians for product detailing, between 2006 and 2012. Accordingly, the paper analyzed the association between detailing policies enacted at these AMCs and the physicians’ prescribing of actively detailed and not detailed drugs. This study included 16,121, 483 prescriptions, written between January 2006 and June 2012, by 2126 attending physicians, at the 19 intervention group AMCs, and by 24, 593 matched control group physicians.

The authors concluded with a fresh reaffirmation that the implementation of policies at AMCs, which restricted product detailing by the respective company medial representatives, between 2006 and 2012, was associated with a modest but statistically significant reduction in prescribing of detailed drugs across 6 of 8 major drug classes.

Significant cost reduction, with important economic implications:

It’s worth noting, the patients did not suffer at all, in any way, with such restrictions, on the contrary were probably benefitted with this policy, though individual pharma player’s sales revenue might have been adversely impacted.

Quoting the researchers, a Public Release of May 2, 2017 titled, “Restricting sales visits from pharmaceutical reps associated with changes in physician prescribing” also reiterates: The reduction in the prescribing of detailed drugs and the increase in the prescribing of non-detailed drugs potentially represent a large reduction in costs, with important economic implications.

Why aren’t the erring players brought to justice in India?

Instances of serious marketing malpractices of several pharma companies in India are also being widely reported from time to time, both by the international and national media, including expressions of serious concern in the Parliament, and a reported Public Interest Litigation (PIL) pending in the Supreme Court.

Any instances of levying massive fines, or other punitive measures taken by any competent Indian authority for such delinquency by many pharma companies operating in the country, have not been reported, just yet, in my view. This is because, India doesn’t have in place any specific regulatory mechanism with built-in legal teeth that would deter, detect, investigate and take exemplary punitive actions against the erring players, wherever justifiable.

Is the department of pharma on the same page as the PM?

Much before this recent development, the Department Related Parliamentary Standing Committee on Health and Family Welfare in its 58th Report, placed before the Parliament on May 08, 2012, strongly indicted the Department of Pharmaceuticals (DoP) for not taking any tangible action in this regard. The committee observed that the DoP should take immediate action in making the ‘Uniform Code of Pharmaceutical Marketing Practices (UCPMP)’ mandatory to contain ‘huge promotional costs and the resultant add-on impact on medicine prices’.

It has just been reported, soon after the Prime Minister’s hint for a legal framework mandating doctors to prescribe in generic names, 73 percent doctors surveyed across the country opposed the PM’s initiative, raising concerns about the quality of all non-branded generic drugs. The report further stokes the apprehension of a concerted effort by this alleged nexus to further strengthen the make-believe perception, sans requisite credible favorable evidence, that branded-generics as a category is superior in quality to non-branded generics, which is not the fact.

Unfortunately, nothing substantive has yet happened on the ground regarding this issue, except the announcement of voluntary implementation of the DoP’s ‘Uniform Code of Pharmaceutical Marketing Practices (UCPMP)’, effective January 1, 2015 for six months for its assessment. Thereafter, the date extension process on the voluntary implementation of the UCPMP has become a routine exercise for the DoP on various pretexts, such as continuing discussion with the pharma trade associations and other stakeholders or to give legal teeth into it with penal provisions.

This situation prompts an important question: Is the DoP on the same page with the PM to contain, if not eliminate, the alleged unholy doctor-drug industry nexus?

Scope of mandatory UCPMP goes beyond prescriptions with generic names:

The scope of several intricate types of marketing malpractices, goes well-beyond influencing prescriptions for brand name drugs, due to various reasons. Hence, what Prime Minister Modi recently hinted at is not an alternative or a replacement for UCPMP, which will fall within a legal framework and be applicable to all the concerned players. Although, there could possibly be some degree of overlap with the prescriptions in generic names, mainly from the perspective of protecting patients’ health interest, the scope of both these initiatives is mutually exclusive, in many respects.

This would also encourage, especially the millennial generation, for innovative strategic thinking to work out cutting edge pharma marketing game plans with active patient engagement, while charting the uncharted frontiers, despite prescriptions in generic names, as and when it comes, if at all. As a result, new warhorses with proven cerebral power and agility would get newer opportunities to hold the leash and occupy the center stage in the pharma marketing warfare.

But…the indefinite wait continues:

Although the DoP apparently maintains a radio-silence on this important issue, a media report of February 26, 2017 indicates that the department will ‘soon’ issue an order making UCPMP mandatory for the drug manufacturing industry, bringing all doctors, chemists, hospitals and states in its ambit, and a blanket ban on expensive freebies such as cruise or vacation tickets. Intriguingly, no one seems to know how ‘soon’ would this ‘soon’ be – hence, the agony of an indefinite wait for justice continues.

Conclusion:

For the last three and a half decades, ‘Code of Pharmaceutical Marketing Practices’, prepared by various global pharma trade associations and many large global pharma companies individually, has come into existence for ‘strictest’ voluntary adherence. These are being relentlessly propagated by them as a panacea for all marketing malpractices in the drug industry.

Squeaky clean ‘pharma marketing codes for voluntary practices’ can be seen well placed in the websites of almost all large global pharma players and their trade associations. Although, its concept and intent are both commendable, a regular flow of media reports on such malpractices raises a relevant question: Do the votaries, sponsors and creators of these codes “walk the talk”?

If yes, why then mind boggling sums in billions of dollars are being paid as settlement fees by a large number of global pharma companies for alleged colossal marketing malpractices in different countries of the world.

This scenario prompts many stakeholders believe, though over-hyped by the global pharma industry, ‘Voluntary Practices’ alone of Pharma Marketing Code’, has never worked anywhere in the world. Thus, India needs a legally binding UCPMP for all concerned.

Prime Minister Modi has hinted at an effective pathway to mitigate this malevolent nexus for the benefit of patients. Understandably, that way can’t be construed as an exhaustive one, nor a cure-all. A slew of other effective steps should follow from different Government authorities, in tandem. The Union Ministry of Health has, at least, taken a related measure falling in their space. Nevertheless, an intriguing apathy of the DoP, as it were, in this area would encourage many to ponder: Is this important Government department on the same page as the PM in containing the alleged ‘doctor – pharma industry nexus?’

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.

 

How Cost-Effective Are New Cancer Drugs?

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The main reason why cancer is so serious a disease, is the ability of the malignant cells to spread in the body, both locally by moving into nearby normal tissue, and regionally to nearby lymph nodes, tissues, or organs, affecting even the distant parts of the body. When this happens, doctors term it as metastatic or stage IV (four) cancer.

Although most patients with metastatic tumors would eventually die of cancer, the treatment with various types of anticancer drugs, could help prolong life, in varying degree. No wonder, many new anticancer drugs now obtain regulatory approval based on their effectiveness on metastatic cancer patients. Consequently, it has now become almost a routine to administer newer anticancer drugs to patients with early stage of disease, after they have undergone surgery or radiotherapy.

But, these lifesaving drugs are expensive – very expensive! For example, a newer anticancer treatment is often priced at US$ 100,000 or more per patient, which, obviously, a large majority of the population can’t just afford.

Are these new drugs cost-effective?

To put in simple words, cost effectiveness of a drug is generally ‘expressed in terms of a ratio where the denominator is a gain in health from a measure (years of life, premature births averted, sight-years gained) and the numerator is the cost associated with the health gain.’

From this perspective, a January 2015 research study titled, “Pricing In The Market For Anticancer Drugs”, published by the National Bureau Of Economic Research of the United States observed that anticancer drugs like bevacizumab (US$ 50,000 per treatment episode) and ipilimumab (US$120,000 per episode) have fueled the perception that the launch prices of anticancer drugs are fast increasing over time.

To evaluate the pricing trend of these drugs, the researchers used an original dataset of 58 anticancer drugs, approved between 1995 and 2013, and found that launch-prices, adjusted for inflation and drugs’ survival benefits, increased by 10 percent, or about US$ 8,500, per year. This study was restricted to drugs administered with the primary intent of extending survival time for cancer patients and drugs for which survival benefits have been estimated in trials or modeling studies. The researchers did not consider drugs administered to treat pain or drugs that are administered to alleviate the side effects of cancer treatments.

The paper concluded, as compared to the older ones, newer anticancer treatments, generally, are less cost-effective. Despite this fact, the prices of these drugs are rising faster than their overall effectiveness.

How much do these drugs cost to prolong a year of life for cancer patients?

Another paper, titled “Cancer Drugs Aren’t As Cost-Effective As They Used To Be”, published in the Forbes magazine on September 30, 2015, expressed serious concern on the declining cost-effectiveness of new anticancer drugs. The author termed this trend as unacceptable, and more disturbing when providing just a year of life to cancer patients costs around US$ 350,000 to even US$ 800,000. High prices should reflect large benefits, and we need to demand value out of medical interventions – he recommended.

Do the claims of efficacy also reflect the real-world effectiveness?

Providing an answer to this question, a very recent article titled, “Assessment of Overall Survival, Quality of Life, and Safety Benefits Associated With New Cancer Medicines”, published in the well reputed medical journal ‘JAMA Oncology’ on December 29, 2016, concluded as follows:

“Although innovation in the oncology drug market has contributed to improvements in therapy, the magnitude and dimension of clinical benefits vary widely, and there may be reasons to doubt that claims of efficacy reflect real-world effectiveness exactly.”

As stated above, this conclusion was drawn by the researchers after a detail study on the overall survival, quality of life, and safety benefits of recently licensed cancer medicines, as there was a dearth of evidence on the impact of newly licensed cancer medicines.

The authors analyzed in detail health technology assessment reports of 62 cancer drugs approved in the United States and Europe between 2003 and 2013, and found that these were associated with increased overall survival by an average of 3.43 months between 2003 and 2013. Following is a summary of the detail findings:

  • 43 percent increased overall survival by 3 months or longer
  • 11 percent by less than 3 months
  • 30 percent was not associated with any increase in overall survival, which means almost one third of these drugs lacked evidence to suggest their increased survival rate when compared to alternative treatments
  • Most new cancer drugs, though improved quality of life, were associated with reduced patient safety

The researchers expect this study to support clinical practice, and promote value-based decision-making in the cancer drug treatment, besides assessing their cost-effectiveness.

Some overseas Cancer Institutes protested:

In 2012, doctors at the Memorial Sloan-Kettering Cancer Center reportedly announced through ‘The New York Times’ that their hospital would not be using Zaltrap, a newly patented colorectal cancer drug at that time, from Sanofi. This action of the Sloan-Kettering doctors compelled Sanofi to cut the price of Zaltrap by half.

Unlike India, where prices of even cancer drugs do not seem to be a great issue with the medical profession, just yet, the top cancer specialists of the American Society of Clinical Oncology are reportedly working out a framework for rating and selecting cancer drugs not only for their benefits and side effects, but prices as well.

In a 2015 paper, a group of cancer specialists from Mayo Clinic also articulated, that the oft-repeated arguments of price controls stifle innovation are not good enough to justify unusually high prices of these drugs. Their solution for this problem includes value-based pricing and NICE like body of the United Kingdom.

This Interesting Video from Mayo Clinic justifies the argument.

Was it a tongue-in-cheek action from India?

On March 9, 2012, India did send a signal to global pharma players on its apparent unhappiness of astronomical pricing of patented new cancer drugs in the country. The then Indian Patent Controller General, on that day, issued the first ever Compulsory License (CL) to a domestic drug manufacturer Natco, allowing it to sell a generic equivalent of a kidney cancer treatment drug from Bayer – Nexavar, at a small fraction of the originator’s price.

However, nothing has changed significantly since then on the ground for cancer drugs in the country. Hence, many construe the above action of the Government no more than mere tokenism.

In this context, it won’t be out of place recapitulating an article, published in a global business magazine on December 5, 2013 that quoted Marijn Dekkers, the then CEO of Bayer AG as follows:

“Bayer didn’t develop its cancer drug, Nexavar (sorafenib) for India, but for Western Patients that can afford it.”

Whether, CL is the right approach to resolve allegedly ‘profiteering mindset’ at the cost of human lives, is a different subject of discussion.

VBP concept is gaining ground: 

The concept of ‘Value-Based Pricing (VBP)’, has started gaining ground in the developed markets of the world, prompting the pharmaceutical companies generate requisite ‘health outcome’ data using similar or equivalent products.

Cost of incremental value that a product delivers over the existing ones, is of key significance, and should always be the order of the day. Some independent organizations such as, the National Institute for Health and Clinical Excellence (NICE) in the UK have taken a leading role in this area.

Intriguingly, in India, public health related issues, however pressing these are, still do not seem to arrest much attention of the government to provide significant relief to a large majority of population in the country.

Conclusion:

Warren Buffet – the financial investor of global repute once said, “Price is what you pay. Value is what you get.” Unfortunately, this dictum is not applicable to the consumers of high priced life-saving drugs, such as, for cancer.

Prices of new drugs for the treatment of life-threatening ailments, such as cancer, are increasingly becoming unsustainable, across the world, and more in India. As articulated by the American Society of Clinical Oncology in 2014, this is mainly because their prices are disconnected from the actual therapeutic value of products.

Currently, a sizable number of poor and even middle-income patients, who spend their entire life’s saving for treatment of a disease like cancer, have been virtually priced out of the patented new cancer drugs market.

The plight of such patients is worse in India, and would continue to be so, especially when no trace of Universal Health Care/Coverage (UHC) is currently visible anywhere near the healthcare horizon of the country.

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.

How Expensive Is Drug Innovation?

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High prices for patented drugs are quite often attributed to the exorbitant cost of drug innovation, by the global pharma players. This argument is played, replayed again, again… and again by them, in various ways and forms, especially when many eyebrows are raised, failing to fathom the primary reason for ever escalating prices of life-saving new drugs.       

I find the same argument often getting echoed by some section of both the global and local media too, and also through some cleverly disguised and apparently sponsored articles on the subject. 

In this article I shall dwell on this sensitive issue.

A strong justification: 

The Institute for Policy Innovation (IPI) based in Texas in the United States, in an article titled “The High Cost of Inventing New Drugs–And of Not Inventing Them”, published on April 16, 2015 reiterated that the financial cost of developing new drugs is indeed a big one.

It argues that “there is also a big cost to not developing new drugs, and that cost can be both financial and human. People may be able to live with the pain that an undiscovered drug might have alleviated, but they may not be able to do all the things they would have.”

The paper asks, “A cancer patient might still have a few productive years after a diagnosis, but how much would it be worth to the patient—and to society (think Steve Jobs), if a new drug could extend a patient’s life indefinitely?”

“The drug manufacturers poured money into finding a treatment for AIDS once it became clear the disease would take thousands of lives. The research and development was costly and didn’t emerge overnight, but being diagnosed with AIDS is no longer a death sentence,” the authors elucidated.

This is a very cogent argument, and nobody would dispute it. This issue lies somewhere else, as I would try to explore in this article.

The supporting data: 

We also find supporting published data to justify the high cost of innovation with numbers.

On November 18, 2014, a new study by the ‘Tufts Center for the Study of Drug Development’ highlighted that developing a new prescription medicine and gaining its marketing approval, which is a process often lasting longer than a decade, is estimated to cost US$ 2,558 million.” This number is indeed mind boggling by any yardstick.

While many details of the study remain a secret, only slightly more than half of this cost is directly related to research and development (R&D). For example, US$ 1.2 billion are “time costs” – returns that investors might have made if their money wasn’t tied up in developing a particular drug.

Not many takers:

Besides the above reason, for several other factors, there does not seem to be many takers for this exorbitant cost of innovation and bringing a new drug to the market.

The above study has become a contentious one and has, therefore, been challenged by many experts. I would give here just one example, out of many, from a highly credible source.

May 14, 2015 issue of ‘The New England Journal of Medicine’ questioned the methods used to generate the US $ 2.6 billion figure and raised the following interesting points in the above Tufts Center study: 

  • The analysis was based on data that 10 unnamed drug makers provided on 106 unnamed investigational compounds that they had “self-originated.”
  • The raw numbers on which the analysis is based are not available for transparent review, and are likely never to be divulged. 
  • Since a balanced assessment would have to take into account the costs of failures as well as successes, it is hard to evaluate the key assumption that more than 80 percent of new compounds are abandoned at some point during their development, which is a key driver of the findings.
  • Nearly half the total cost of developing a new drug (US$ 1.2 billion) was ascribed to this cost of capital, with only US$ 1.4 billion attributed to the funds actually spent on research. These capital costs were assessed at 10.6 percent per year, compounded, despite the fact that bonds issued by drug companies often pay only 1 to 5 percent.
  • In terms of access to capital, it’s interesting to note that large drug makers are among the U.S. firms with the highest amounts of profits held overseas. Two pharmaceutical companies are ranked third and fourth among all the U.S. corporations in this regard: Pfizer (US$ 69 billion) and Merck (US$ 57 billion), respectively. Collectively, another eight drug companies reportedly have an additional US$ 173 billion of capital that is retained overseas, untaxed by the United States. Such funds could potentially help with the cash-flow problem that plays such a large role in these estimated costs of drug development.
  • The Tufts calculations also explicitly do not take into account the large public subsidies provided to pharmaceutical companies in the form of research-and-development tax credits or substantial payments received from the federal government for other research activities, such as testing their products in children. 
  • The US$ 2.6 billion figure does not consider drug-development costs borne by the public for the large number of medications that are based on external research that elucidated the disease mechanisms they address.
  • One recent analysis showed that more than half of the most transformative drugs developed in recent decades had their origins in publicly funded research at nonprofit, university-affiliated centers.
High innovation cost fails to justify high drug prices:

That even the high cost of innovation fails to justify high drug prices, was also echoed in an article published in ‘The New York Times’ on December 19, 2015.

The article categorically said, ‘there is ample evidence that drug prices have been pushed to astronomical heights for no reason other than the desire of drug makers to maximize profits. Prices in many cases far exceed what’s needed to cover the costs of research and clinical trials, and some companies have found ways to rake in profits even without shouldering the cost of drug development.’

Yet another justification of high new drug prices:

Yet another justification of a slightly different kind also frequently comes from the global pharma players for high prices of new drugs.

On May 2, 2015 ‘The Washington Post’ also published an article, which recapitulated this oft repeated justifications for keeping the prices of new drugs high, especially those for rare diseases, including many types of cancer. The key rationale of this argument: the smaller is the number of patients who need the drugs, more would be the need of the company to price the drugs high to recoup the significant costs of drug development.

On the face of it, this justification too may sound convincing. However, on the ground, even if this argument of the global drug companies fails to stand on its feet, post robust scrutiny of the experts. In that context, I shall cite two recent examples.

Two new research studies broke this myth too:

The Following two April 2016 study conclusively demolishes the above justification of the global drug companies:

1. On April 28 2016, a new study was published in  JAMA Oncology, throwing  a great deal of light on the robustness of the above reasoning. In this paper, the researchers looked at 32 oral cancer medications and found that launch prices of these drugs have spiraled upward, even after adjusting for inflation. The average monthly amount insurers and patients paid for a new cancer drug was less than US$ 2,000 in the year 2000, but it skyrocketed to US$ 11,325 in 2014. 

2. In April 2016, another study published in Health Affairs found, when a drug became useful to a larger number of patients, the price also shot up. It, therefore, concluded as follows:            

“Our findings suggest that there is currently little competitive pressure in the oral anticancer drug market. Policy makers who wish to reduce the costs of anticancer drugs should consider implementing policies that affect prices not only at launch but also later.”              

Are high new drug prices, then arbitrary?

According to a July 2015 article published in JAMA Oncology, the high prices of new drugs, especially for cancer, are arbitrary. This is vindicated in the discussion of the article that clearly states, as follows: 

“Cancer drug prices are rising faster than the prices in other sectors of health care, drawing concern from patients, physicians, and policy researchers. We found little difference in the median wholesale price of 21 novel drugs and 30 next-in-class drugs approved over a 5-year period (next-in-class drugs, $119 765; novel drugs, $116 100; P = .42).”

“Our results suggest that the price of cancer drugs is independent of novelty. Additionally, we found little difference in price among drugs approved based on time-to-event end points and drugs approved on the basis of RR (disease Response Rate). Our results suggest that current pricing models are not rational, but simply reflect what the market will bear.” 

Thus, the derived fact is, the high prices of new drugs are neither dependent on high cost of drug innovation, nor on the number of drug users – high or low. Higher drug prices, therefore, appear to be nothing but arbitrary, the public justifications being no more than façades. 

Is the real cost of drug innovation much less?

This question brings me back to the moot point, ‘What is then the real financial cost of drug innovation?’

The search for a generally acceptable answer to this question gets even more complicated, when one reads the paper of The Bureau of Economics, Federal Trade Commission’ in Washington, DC, published on March 7, 2006 in Health Affairs – the leading journal of health policy thought and research.

The paper estimates the cost per new drug to be US US$ 868 million. However, it says, “Our estimates vary from around US$ 500 million to more than US$ 2,000 million, depending on the therapy or the developing firm. The paper recommended that variations in cost estimates suggest that policymakers should not use a single number to characterize drug costs.

Conclusion:

This situation arises, because the drugs with brand names, whether patented or off-patent, do not compete on price in the pharma market, across the world. The primary reason being a consumer is neither the prescription decision makers nor can they exercise their brand choice in any manner. For any patients, a doctor always takes this decision, who is often influenced by the drug manufacturers, and may not be even aware of the drug price, as is generally alleged, globally.

This process is quite unlike to any other essential commodities. However, the ongoing marketing campaigns for branded drugs are quite a keen to commonly used consumer goods, carrying brand names and backed by high profile branding campaigns, where high prices rather add greater perceived value to the brand status.

But the irony is glaring. The administration of life-saving highly expensive drugs is not optional for any patient, whether poor or rich. These are necessary to save lives. Thus, does not merit arbitrary high-profit driven pricing, at least, from the standpoint of patient-centric ethical business practices.

It still happens, even at the cost of access to such drugs by a large majority of the global population, who requires them the most. In all probability, this process is likely to continue in the near future too, irrespective of the quest of many to fathom how expensive is the drug innovation, unless the government or other payers actively intervenes. I shall discuss this issue in my next article in this Blog. 

Nevertheless, the answer to the crucial question, ‘How expensive is the drug innovation’ would continue to remain elusive to many, at least in the near term. This because, no global drug company is likely to allow any competent and independent experts group to arrive at this number in a transparent manner, which can also be peer reviewed. Nor would the pharma players, in all probability, furnish this information to any Government to justify the high price of their respective new brands.

Till this is done, pricing decisions of new lifesaving drugs would continue to remain arbitrary, primarily driven by high-profit motives. It is unlikely to have even a remote direct linkage to the cost of drug innovation, limited consumer access notwithstanding, just as what happens with many branded consumer goods.

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.

 

Marketing Off-label Use of Drugs: A Path Much Abused?

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As many would know, prescribing any medicine for disease conditions that are not approved by the drug approving authorities while granting its marketing approval, is generally termed as ‘off-label’ use of drugs.

It is also a usual practice in most of the regulated markets of the world that once the drug regulators give marketing approval of a medicine, which is indication-specific, physicians are free to prescribe these as they deem necessary. However, the drug manufacturers can seek prescription support from the doctors only for the indications as approved by the appropriate government authorities.

Even the USFDA had articulated, “the best way to address any concerns that the information about those (off-label) uses is not reaching medical practitioners is to get those uses in the labeling. We believe that the risks of allowing drug companies to distribute journal articles and other information about off label uses far outweigh any benefits.”        

Since long, most of the drug regulators across the world, including the Drug Controller General of India (DCGI) have prohibited the sales promotion for unapproved uses of drugs to doctors. Nevertheless, the practice continues ignoring its serious consequences.

Monitoring of ‘off-label’ use is challenging: 

Monitoring of off-label use of medicines is quite challenging too by the drug regulators, especially in India, where post marketing surveillance is generally just on paper.

In this regard, a recent research study that I shall refer to below in this article, has quite appropriately suggested, “Future electronic health records should be designed to enable post market surveillance of treatment indications and treatment outcomes to monitor the safety of on and off-label uses of drugs.”

As India intends to move towards the ‘Digital’ space, this suggestion would be quite implementable by the DCGI, as the ‘Smart Cities’ start coming up.

Some examples of extensive off-label usages: 

According to the study done by a team of experts in medical information – Iodine, using the top drugs by number of monthly prescriptions, the following is a list of 4 medications with surprising off-label uses:

Drug Approved Indication Off-label Indication
Abilify (Aripiprazole) Schizophrenia, Bipolar Disorder, Major Depressive Disorder (adjunctive), Autism-related Irritability, Agitation associated with Schizophrenia or Bipolar Mania, other Insomnia
Lyrica (Pregabalin) Management of: neuropathic pain associated with diabetic peripheral neuropathy, post herpetic neuralgia, fibromyalgia, neuropathic pain associated with spinal cord injury; adult patients with partial onset seizures (adjunctive) Anxiety
Namenda (Memantine) Moderate to severe dementia of the Alzheimer’s type ADHD, OCD
Synthroid (Levothyroxine) Low thyroid hormone levels, some types of goiters, management some types of thyroid cancers Depression

Off-label use and increasing risks of drug safety: 

In its November 02, 2015 online issue, JAMA Internal Medicine published an article titled, “Association of Off-Label Drug Use and Adverse Drug Events (ADE) in an Adult Population.” The objective of this study was to monitor and evaluate off-label use of prescription drugs and its effect on ADEs in an adult population.

This particular study assumes importance, as off-label use of prescription drugs without strong scientific evidence has been identified as an important contributor to preventable Adverse Drug Events (ADEs), especially in children. However, despite concerns in this regard, no systematic investigation on the effects of off-label drug use in adult populations is being performed, regularly.

The detail analysis of this study reveals that not only is the benefit of off-label prescription is uncertain, but the risks of ADEs could make the ‘risk-benefit ratio’ quite unfavorable. So much so that in a large number of cases, no drug treatment will be a much better option.

According to the authors, the risk for ADEs grew as the number of prescription drugs the patient used increased. For example, patients using eight or more drugs had more than a 5-fold increased risk for ADEs compared with patients who used one to two drugs.

The study involving 46,021 adult patients, receiving 151,305 prescriptions between January 2005 and December 2009 was done in Canada. Of those prescriptions, more than 10 percent were prescribed for off-label use. Interestingly, out of that group, more than 80 percent prescriptions were for off-label uses without any robust scientific evidence supporting the use.

Based on the findings the researchers concluded that off-label use of prescription drugs is associated with ADEs.

The article suggested:

  • Caution should be exercised in prescribing drugs for off-label uses that lack strong scientific evidence.
  • Future electronic health records should be designed to enable post market surveillance of treatment indications and treatment outcomes to monitor the safety of on and off-label uses of drugs.

Pharma industry strongly opposes off-label use, when it suits them:

Interestingly, pharma industry vehemently opposes off-label use of drugs, when it suits them.

To give just a couple of examples, recently a new law that permits prescribing of drugs for off-label uses in France has reportedly been strongly opposed by the pharmaceutical industry in Europe.

Pharma trade associations argue, “the above move of France is directly in opposition to European Union’s laws that prohibit member states from supporting off-label use for economic purposes, and is a trend that undermines the current regulatory framework and could put patients’ health at risk.”

Besides France, they have also submitted a complaint against Italy to the European Commission over the country’s new off-label rules.

Common methods followed for off-label marketing:

The other side of the story is that, reportedly many pharma companies continue promoting off-label uses of drugs aggressively, for significant commercial gains.

According to ‘The Centers for Medicare & Medicaid Services (CMS) – a federal agency within the United States Department of Health and Human Services, some of the off-label drug promotion methods of the pharmaceutical companies are as follows:

• Paying incentives to sales representatives based on sales for off-label use

• Paying kickbacks to physicians to prescribe drugs for off-label use

• Disseminating misleading posters promoting off-label use

• Paying physicians:

- To pretend to be the authors of articles about off-label uses when the articles were actually written by manufacturers’ agents

- To serve as members of “advisory boards” promoting off-label use

- To travel to resort locations to listen to promotions about off-label use

- To give promotional lectures in favor of off-label use to fellow practitioners

• Publicizing studies showing efficacy of off-label uses, while suppressing studies showing no efficacy.

Even the Uniform Code of Pharmaceutical Marketing Practices (UCPMP) of the Government of India does not allow such sales and marketing practices. But these all continue to happen, unabatedly.

A path much abused?

Although most of the drug companies publicly advocate self regulation to avoid unethical marketing practices, the situation on the ground is much different, across the world. 

The following are just a few examples of serious business consequences faced by some of the well-known global pharma and biotech majors, besides many others, from the United States Department of Justice, for alleged off-label promotion of drugs: 

  • On November 4, 2013, Johnson & Johnson (J&J) was asked to pay more than US$ 2.2 billion to resolve criminal and civil liability arising from allegations relating to the prescription drugs Risperdal, Invega and Natrecor, including promoting for uses not approved as safe and effective by the USFDA and payment of kickbacks to physicians and to the nation’s largest long-term care pharmacy provider.  
  • On July 30, 2013, Wyeth Pharmaceuticals Inc., a pharmaceutical company acquired by Pfizer, Inc. in 2009, agreed to pay US$490.9 million to resolve its criminal and civil liability arising from the unlawful marketing of the prescription drug Rapamune for uses not approved as safe and effective by the USFDA. 
  • On December 19, 2012, Amgen Inc. pleaded guilty and paid US$762 million to resolve criminal liability and false claims allegations.
  • On July 2, 2012 GlaxoSmithKline LLC (GSK) pleaded guilty and paid US$3 billion to resolve its criminal and civil liability arising from the company’s unlawful promotion of certain prescription drugs, its failure to report certain safety data, and its civil liability for alleged false price reporting practices. This resolution is the largest health care fraud settlement in the US history and the largest payment ever by a drug company, so far. 
  • On May 7, 2012, Abbott Laboratories Inc. pleaded guilty and agreed to pay US$1.5 billion to resolve its criminal and civil liability arising from the company’s unlawful promotion of the prescription drug Depakote for uses not approved as safe and effective by the USFDA.  This resolution is the second largest payment by a drug company and includes a criminal fine and forfeiture totaling US$700 million and civil settlements with the federal government and the states totaling US$800 million.  Abbott also was reportedly subjected to court-supervised probation and reporting obligations for Abbott’s CEO and Board of Directors.
  • On October 21, 2011, Pfizer Inc. agreed to pay US$14.5 million to resolve false claims allegations related to its marketing of the drug Detrol. 
  • On June 10, 2011, Novo Nordisk was asked to pay US$25 million to resolve allegations of off-label promotion of Novoseven.
  • On September 30, 2010, Novartis agreed to pay US$422.5 million to settle criminal and civil investigations into the marketing of the anti-seizure medicine Trileptal and five other drugs. The government accused Novartis of mislabeling, paying illegal kickbacks to health care professionals through speaker programs, advisory boards, entertainment, travel and meals. 

Hence, it appears that the path followed by many pharma players to inform the doctors about the judicious off-label use of drugs only in circumstances where approved treatments have failed, is being much abused. 

A conflict of interest? 

Many doctors believe that there is also a distinct upside for off-label use of drugs, as flexibility of a physician to prescribe drugs off-label offers important advantages too, especially in circumstances where approved treatments have failed. This is indeed true and indisputable.

However, the reality is, many pharma industry, in general, actively encourage off-label use of drugs for commercial benefits through expanded use of their respective brands.

Aggressive drug promotion for various off-label uses, reportedly being so widespread and indiscriminate, many physicians can’t even remember the approved indications of drugs. Hence, they do not necessarily go for off-label use only when approved treatments have failed.  In this context, on November 23, 2015, ‘The Wall Street Journal (WSJ)’ in an article titled, “Risk of Off-Label Uses for Prescription Drugs” reported as follows:

“A 2009 study published in the journal Pharmacoepidemiology and Drug Safety found that 1,199 physicians in a national survey were able to identify the FDA-approved indication of 22 drugs only about 55% of the time. The physicians surveyed included primary-care doctors and psychiatrists.” 

On the other hand, the patients generally expect that the prescribed drugs will be safe. They want to administer evidence based approved medicines. Some of them have even started expressing that these evidences must also be disclosed to them.

Hence, there seems to exist a clear conflict of interest in this matter between the patients, drug manufacturers and perhaps the doctors, as well.

Conclusion:

The magnitude of general off-label use of drugs is reportedly increasing and is likely to increase further, exposing patients to increased risks of ADEs.  Although the business consequences of getting engaged in this unwanted process indiscriminately could at times be quite adverse, in the balance of probability between slim chances of getting caught, and expected creamy return, many pharma players continue to feel that this risk is worth taking.

Therefore, the moot question that needs a pragmatic answer is, for patients’ safety, when the global and local pharma majors talk about prescriptions of only impeccable evidence based medicine, do they walk the talk?

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.

 

Unsustainable New Cancer Drug Prices: Resolution Remains A Far Cry

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Prices of new drugs for the treatment of life-threatening ailments, such as cancer, are increasingly becoming unsustainable, across the world, and more in India. As articulated by the American Society of Clinical Oncology in 2014, this is primarily due to the fact that their prices are disconnected from the actual therapeutic value of products.

Today, a very large number of poor and even the middle-income patients, who spend their entire life-savings for treatment of a disease like cancer, have been virtually priced out of the patented new drugs market.

The plights of such patients are worse in India and would continue to be so, especially when no trace of Universal Health Care/Coverage (UHC) is currently visible anywhere near the healthcare horizon of the country.

I discussed about the recent decision of the Government for shelving UHC in my recent Blog Post titled, “Would Affordable ‘Modicare’ Remain Just A Pipe Dream In India?”

Irresponsible pricing?

To highlight this point, I shall quote from the research paper titled, “Five Years of Cancer Drug Approvals, Innovation, Efficacy and Costs” published in JAMA Oncology dated April 02, 2015. This report states that just one year’s cost of treatment with a patented new cancer drug now routinely exceeds US$ 100,000. It is much known today that the medical bills for cancer treatment have become the single largest cause of personal bankruptcy, in many countries of the world.

The issue is even more impactful and heart wrenching in India, as with much lower per capita income, compared to the global median, a cancer patient pays around the same price for the same patented drugs in the country. Much talked about Nexavar of Bayer, has been a good example.

The above report underscores, the big global pharma players still vigorously contend to establish that the high cost of drugs is required to support their research and development efforts. However, none would possibly deny the hard data that, when costs and revenues are balanced, the pharmaceutical industry generates high profit margins.

On a lighter vain – the fact that the richest person in India is a pharma player of ‘low price generic medicines’ vindicates this point.

The latest report on pharma R&D costs:

In a ‘Press Release’ of November 18, 2014, Tufts Center for the Study of Drug Development announced, “Cost to develop and win marketing approval for a New Drug is US$2.6 Billion”.

This is around 2.5 times more than its previous estimate published in 2003, which reads as US$802 million.

Although the study is not publicly available, neither has it been peer reviewed, it does reflect that above overall inflation rate, pharma R&D costs are reportedly going up at an annual rate of around 8 percent!

Even if the R&D cost of US$2.6 Billion is accepted as correct to justify high prices of patented drugs, one should note that this figure is applicable only to those types of New Chemical Entities (NCE) that did not receive any outside funding in their developmental process, such as, from the National Institutes of Health (NIH).

It is worth noting, such types of NCEs account for less than one-sixth of the annual new drugs approval in the United States.

Interestingly, Tufts Center receives its funding from the pharmaceutical industry, according to reports.

When is a high cost of medicine defendable?

According to some, high price may be justified, if novel products offer significant benefits to patients giving rise to indirect quantifiable economic value through restoration of health of patients.

This is understandable, as those patented drugs represent significant and well-accepted pharmacological advances over the existing ones, offering novel mechanisms of actions for better treatment value through ‘high-risk-high-cost’ research.

Price is a function of the value that a drug offers:

The price of any drug must be a function of the value that it offers to the patients. Not just the cost of its innovation, irrespective of the fact, whether it is a ‘New-Class (Novel)’ or ‘Next-in Class’ or even a ‘Me-too’ NCE.

The above April 2015 research report published in JAMA Oncology, investigated at length, whether novelty of medications or their relative benefits dictated drug pricing.

In that endeavor, the authors found out that from January 1, 2009, to December 31, 2013, the USFDA approved 51 drugs in oncology for 63 indications. During this period, 9 drugs received more than 1 approved indication.

The study observed:

Of these 51 drugs:

- 21 (41 percent) exert their effect via a novel mechanism of action

- While 30 (59 percent) are next-in-class drugs

Despite this fact, there was no difference in the median price per year of treatment between the 30 next-in-class drugs (US$119, 765) and the 21 novel drugs (US$116, 100).

Global cancer market is soaring high fuelled by astronomical prices:

According to a report that quotes an official of IMS Health, the overall cost for cancer treatments per month in the United States is now US$10,000, up from $5,000 just a year ago. At the same time, according to a 2014 study by the IMS Institute for Healthcare Informatics, global oncology spending has hit US$91 billion in 2013, and despite patent cliff is growing at 5 percent annually.

None likes nightmarish cancer drug-pricing trend:

None likes this worrisome drug-pricing trend, not even in the developed world. God forbid, just one cancer patient in the family can drag even a middle class household to the poverty level, especially in a country like India, where Out of Pocket (OoP) expenses for health hovers around 70 percent and Universal Health Coverage still remains a pipe dream.

Payers, including governments and private insurers, in the top cancer markets such as the United States and Europe, are trying hard to bring the cancer drug prices to a reasonable level through regulatory pressure of various kinds and forms. For example, National Institute for Health and Care Excellence (NICE) in the United Kingdom and the regulators for drug cost-effectiveness in other large European countries, are coming hard on patented new cancer drugs with small improvements in survival time but priced much higher than the existing ones.

Even many private insurers in those countries are now raising questions about the additional value offerings in quantifiable terms, especially for the new cancer drugs and other treatments for life-threatening ailments, such as hepatitis C. To give an example, in late 2014, Express Scripts in America negotiated hard for an exclusive deal with AbbVie to provide its hepatitis C treatment Viekira Pak over Gilead’s exorbitantly priced Sovaldi.

Action by the doctors outside India:

In 2012, doctors at the Memorial Sloan-Kettering Cancer Center reportedly announced in ‘The New York Times’ that their hospital would not be using Zaltrap, a newly patented colorectal cancer drug from Sanofi. This action of the Sloan-Kettering doctors compelled Sanofi to cut Zaltrap price by half.

Unlike in India, where prices of even cancer drugs do not seem to be a great issue with the medical profession, just yet, the top cancer specialists of the American Society of Clinical Oncology are reportedly working out a framework for rating and selecting cancer drugs not only on their benefits and side effects, but prices as well.

In a recent 2015 paper, a group of cancer specialists from Mayo Clinic also articulated, that the oft-repeated arguments of price controls stifle innovation are not good enough to justify unusually high prices of such drugs. Their solution for this problem includes value-based pricing and NICE like body of the U.K.

This Interesting Video from Mayo Clinic justifies the argument.

Tokenism by the Indian Government:

India sent a signal to global pharma players about its unhappiness of astronomical pricing of patented new cancer drugs in the country on March 9, 2012. On that day, the then Indian Patent Controller General issued the first ever Compulsory License (CL) to a domestic drug manufacturer Natco, allowing it to sell a generic equivalent of a kidney cancer treatment drug from Bayer – Nexavar, at a small fraction of the originator’s price.

In this context, it won’t be out of place recapitulating that an article published in a global business magazine on December 5, 2013 quoted Marijn Dekkers, the CEO of Bayer AG saying: “Bayer didn’t develop its cancer drug, Nexavar (sorafenib) for India but for Western Patients that can afford it.”

Whether, CL is the right approach to resolve allegedly ‘profiteering mindset’ at the cost of human lives, is a different subject of discussion.

Be that as it may, India did send a very strong signal in this regard, which some construe as mere tokenism. Nonetheless, this action of the Indian Government shook the global pharma world very hard, that it would find difficult to forget in a foreseeable future.

Government’s determination to make it happen is still eluding:

The headline of this article would probably invoke an instant negative response from my friends in the industry, an understandably so, expressing… ‘Hey, are you talking against innovation and suggesting one more regulator for the heavily regulated pharma industry?’ 

I would very humbly say, no…I am suggesting neither of those two, but requesting to give shape to a very important decision already taken by the Government on this issue, in a meaningful way. That decision has been scripted in Para 4.XV of the National Pharmaceutical Pricing Policy 2012 (NPPP 2012) and was notified on December 07, 2012.

On ‘Patented Drugs Pricing’, it categorically states as follows:

“There is a separate committee constituted by the Government Order dated February 01, 2007 for finalizing the pricing of Patented Drugs, and decisions on pricing of patented Drugs would be based on the recommendation of this committee.”

The following long drawn unproductive events would vindicate, beyond even an iota of doubt, that a strong determination to make it happen, by even by the new Government, is still eluding by far.

Is this committee ‘Jinxed’?

To utter dismay of the patients and their well-wishers, the above committee took over six years after it was formed to submit its report.

It recommended ‘Reference Pricing’ for the Patented Drugs in India, after adjusting against India’s Gross National Income and Purchasing Power Parity. The suggested ‘Reference Countries’ were UK, Canada, France, Australia and New Zealand, where there exist a strong public health policy, together with tough bargaining power of the governments for drug price negotiations.

However, our Government found this report useless for various reasons and dissolved the panel. The grapevine in the corridors of power whispers, it could possibly be due to intense pressure from the global pharma players and their powerful lobby groups.

Interestingly, again by the end of 2013, the Department of Pharmaceuticals (DoP) set up a brand new inter-ministerial committee with four representatives each from the Ministry of Commerce and Industry, Ministry of Health and Family Welfare, National Pharmaceutical Pricing Authority (NPPA) and one from the DoP to resolve the same issue of ‘Patented Drugs Pricing’ in India.

Unfortunately, a serious issue of this magnitude has still remained unresolved, even under the new seemingly dynamic Government, till date. There were media reports though, just prior to the Union Budget in January 2015, that ‘the Government may negotiate prices of patented medicines with their manufacturers before allowing pharmaceutical companies to launch them in India.’

The scenario is still far from even sketchy. A lurking fear, therefore, creeps into the minds of many: Is this committee on ‘Patented Drugs Pricing’ jinxed or incompetent or has deliberately been kept non-functional under tremendous external pressure on pricing of patented drugs?

The way forward:

To find an implementable ‘Patented Drug Pricing Model’ soon, the new committee of the Government should consider Pharmacoeconomics Based or Value-Based Pricing (PBP/VBP) Model for the country.

Pharmacoeconomics, as we know, is a scientific model of setting price of a medicine commensurate to the economic value of the drug therapy.  Pharmacoeconomics principles, therefore, intend to maximize the value obtained from expenditures towards medicines through a structured evaluation of products costs and disease outcomes.

Thus, PBP/VBP basically offers the best value for money spent. It ‘is the costs and consequences of one treatment compared with the costs and consequences of alternative treatments’.

To the best of my knowledge, the Public Health Foundation of India, spearheaded by well-reputed internationally acclaimed physician – Dr. Srinath Reddy, has requisite expertise in this area and to build on it further, as required by the committee.

This new model would help establishing in India that the price of any drug is always a key function of the value that it offers and not of the so called ‘high cost of innovation’, irrespective of whether it is a ‘New-Class (Novel)’ or ‘Next-in Class’ or even ‘Me-Too’ NCE.

The concept is gaining ground: 

The concept of ‘Value-Based Pricing’, has started gaining ground in the developed markets of the world, prompting the pharmaceutical companies generate requisite ‘health outcome’ data using similar or equivalent products.

Cost of incremental value that a product delivers over the existing ones, is of key significance and should always be the order of the day. Some independent organizations such as, the National Institute for Health and Clinical Excellence (NICE) in the UK have taken a leading role in this area.

Conclusion:

Warren Buffet – the financial investor of global repute once said, “Price is what you pay. Value is what you get.” Unfortunately, this dictum is not applicable to the consumers of high priced life saving drugs, such as, for cancer.

Price tags of most of the patented new cancer drugs, do not seem to give any indication that the pharma players believe in this pricing model, even remotely. As JAMA Oncology has established in their recent research study, there is no difference in the median price of per year of treatment between ‘Next-in-Class’ and ‘Novel Drugs’.

Thus far, India has been able to address this issue either through section 3(d) or Compulsory Licensing (CL) provisions of its Patents Act. As the saying goes, ‘proof of the pudding is in the eating’, the net fall-out of these measures has been demonstrably profound. For example, the global pharma giant Gilead has entered into voluntary License (VL) agreements with several local companies to market in India one of the most expensive products of the world – Sovaldi, at a small fraction of its original price of US$1,000/tablet. 

That said, effective long-term resolution of ‘Patented Drugs Pricing’ issue, in my view, is long overdue in India, especially for the treatment of life-threatening diseases, such as cancer. This has been necessitated by the fact that in many cases, therapeutic benefits of most of these drugs are not commensurate to their high costs.

The provision for ‘Patented Drugs Pricing’ has already been made in the NPPP 2012, though not implemented, as yet. While working out an implementable mechanism for the same, the new committee of the present Government may consider ‘Pharmacoeconomics Based or Value-Based Pricing (PBP/VBP) Model’ to effectively resolve this crucial issue. The specialized group that will operate this system could be a part of the National Pharmaceutical Pricing Authority (NPPA) of India.

The struggle for life in the fierce battle against dangerous ailments, without having access to new life-saving drugs, has indeed assumed a mind-boggling dimension in India, especially in the absence of Universal Health Coverage. It would continue to remain so, unless the new Government demonstrates its will to act, putting in place a transparent model of patented drugs pricing, without succumbing to any power play or pressures of any kind from vested interests.

The bottom-line is: It has to happen soon…very soon. For patients’ sake.

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.

No More Payment for Prescriptions: Pharma at A Crossroads?

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  • “ARE there different and more effective ways of operating than perhaps the ways we as an industry have been operating over the last 30, 40 years?”
  • “TRY and make sure we stay in step with how the world is changing.”

Those are some introspective outlooks of Sir Andrew Witty – the Chief Executive of GlaxoSmithKline (GSK) related to much contentious pharmaceutical prescription generation processes now being practiced by the drug industry in general, across the world.

The ‘Grand Strategy’ to effectively address these issues, in all probability, was still on the drawing board, when Sir Andrew reportedly announced on December 16, 2013 that GSK:

  • Will no longer pay healthcare professionals to speak on its behalf about its products or the diseases they treat to audiences who can prescribe or influence prescribing.
  • Will stop tying compensation of sales representatives to number of prescriptions the doctors write.
  • Will stop providing financial support to doctors to attend medical conferences.

These iconoclastic intents, apparently moulded in the cast of ethics and values and quite possibly an outcome of various unpleasant experiences, including in China, is expected to take shape worldwide by 2016, as the report indicates.

Acknowledgment of unbefitting global practices:

Reacting to this announcement, some renowned experts, as quoted in the above report, said, “It’s a modest acknowledgment of the fact that learning from a doctor who is paid by a drug company to give a talk about its products isn’t the best way for doctors to learn about those products.”

The world envisages a refreshing change:

A December 11 article in the Journal of American Medical Association (JAMA) stated that there exists a serious financial ‘Conflict of Interest (COI)’ in the relationship between many Academic Medical Centers (AMCs) and the drug and medical device industries spanning across a wide range of activities, including:

  • Promotional speakers
  • Industry-funded ‘Continuing Medical Education (CME)’ programs
  • Free access of sales representatives to its faculty, trainees and staff
  • The composition of purchasing and formulary committees

Such types of relationships between doctors and the pharmaceutical companies across the world, including in India, as studies revealed, have been custom crafted with the sole purpose of influencing prescription behavior of doctors towards more profitable costlier drugs, many of which offer no superior value as compared to already available cheaper generic alternatives.

Cracking the nexus is imperative:

Yet another report says, “Ghost-writing scandals, retracted journal papers, off-label marketing settlements, and a few high-profile faculty dust-ups triggered new restrictions at some schools.”

To address this pressing issue of COI, cracking the Doctor-Industry alleged nexus, which is adversely impacting the patients’ health interest, is absolutely imperative. An expert task force convened by the ‘Pew Charitable Trusts’ in 2012, made recommendations in 15 areas to protect the integrity of medical education/training and the practice of medicine within AMCs.

Some of those key recommendations involving relationships of medical profession with pharmaceutical companies are as follows:

  • No gifts or meals of any value
  • Disclosure of all industry relationships to institutions
  • No industry funded speaking engagement
  • No industry supported Continuing Medical Education (CME)
  • No participation at industry-sponsored lectures and promotional or educational events
  • No meeting with pharmaceutical sales representative
  • No industry-supported clinical fellowships
  • No ghostwriting and honorary authorship
  • No ‘Consulting Relationship’ for product marketing purpose

The above report also comments, “if medical schools follow new advice from a Pew Charitable Trusts task force, ‘No Reps Allowed’ signs will soon be on the door of every academic medical center in the United States.”

MNC pharma associations showcase voluntary ‘Codes of Marketing Practices’: 

Most of the global pharma associations have and showcase self-regulating ‘Codes of Pharmaceutical Marketing Practices’. However, the above GSK decision and hefty fines that are being levied to many large global companies almost regularly in different countries for marketing ‘malpractices’, prompt a specific question: Do these well-hyped ‘Codes’ really work on the ground or are merely expressions of good intent captured in attractive templates and released in the cyberspace for image building?

Global status overview:

In this context an updated article of December 11, 2013 states that Medical Faculty, Department Chairs and Deans continue to sit on the Board of Directors of many drug companies. At the same time, many pharma players support programs of various medical schools and teaching hospitals through financial grants.  Company sales representatives also enjoy free access to hospital doctors to promote their products.

In most states of the United States, doctors are required to take accredited CMEs. The pharmaceutical industry provides a substantial part of billions of dollars that are spent on the CME annually, using this support as marketing tools. This practice is rampant even in India.

The above article also highlights incidences of lawsuits related to ‘monetary persuasion’ offered to doctors. In one such incidence, two patients reportedly fitted with faulty hips manufactured by Stryker Orthopedics discovered that the manufacturer paid their surgeon between US$ 225,000 and US$ 250,000 for “consultation services,” and between US$ 25,000 and US$ 50,000 for other services.

However, since August 2013, ‘Physician Payment Sunshine Act’ of the United States demands full disclosure of gifts and payments made to doctors by the pharma players and allied businesses. Effective March 31, 2014, all companies must report these details to the Centers for Medicare & Medicaid Services (CMS), or else would face punitive fines as high as US$1 million per year. CMS would publish records of these payments to a public website by September 31, 2014. India needs to take a lesson from this Act to help upholding ethics and values in the healthcare system of the country.

Overview of status in India:

As reported by both International and National media, similar situation prevails in India too.

Keeping such ongoing practices in mind and coming under intense media pressure, the Medical Council of India (MCI) on December 10, 2009 amended the “Indian Medical Council (Professional Conduct, Etiquette and Ethics), Regulations 2002″ for the medical profession of India. The notification specified stricter regulations for doctors in areas, among others, gifts, travel facilities/ hospitality, including Continuing Medical Education (CME), cash or monetary grants, medical research, maintaining professional Autonomy, affiliation and endorsement in their relationship with the ‘pharmaceutical and allied health sector industry’.

However, inability of the Indian regulator to get these guidelines effectively implemented and monitored, has drawn sharp flak from other stakeholders, as many third party private vendors are reportedly coming up as buffers between the industry and the physicians to facilitate the ongoing illegal financial transactions, hoodwinking the entire purpose, blatantly.

Moreover, it is difficult to fathom, why even four years down the line, the Department of Pharmaceuticals of the Government of India is yet to implement its much hyped ‘Uniform Code of Pharmaceutical Marketing Practices (UCPMP)’ for the entire pharmaceutical industry in India. 

Learning from other self-regulatory ‘Codes of Pharma Marketing Practices’, in my view, a law like, ‘Physician Payment Sunshine Act’ of the United States, demanding public disclosure of gifts and all other payments made to doctors by the pharma players and allied businesses, would be much desirable and more meaningful in India.

Conclusion:

Research studies do highlight that young medical graduates passing out from institutions enforcing gift bans and following other practices, as mentioned above, are less likely to prescribe expensive brands having effective cheaper alternatives.

The decision of GSK of not making payments to any doctor, either for participating or speaking in seminars/conferences, to influence prescription decision in favor of its brands is indeed bold and laudable. This enunciation, if implemented in letter and spirit, could trigger a paradigm shift in the the prescription demand generation process for pharmaceuticals brands.

However, this pragmatic vow may fall short of stemming the rot in other critical areas of pharma business. One such recent example is reported clinical data fabrication in a large Japanese study for Diovan (Valsatran) of Novartis AG. Had patient records been used in their entirety, the Kyoto Heart Study paper, as the report indicates, would have had a different conclusion.

That said, if all in the drug industry, at least, ‘walk the line’ as is being demarcated   by GSK, a fascinating cerebral marketing warfare to gain top of mind brand recall of the target doctors through well strategized value delivery systems would ultimately prevail, separating men from the boys.

Thus, the moot point to ponder now:

Would other pharma players too jettison the decades old unethical practices of ‘paying to doctors for prescriptions’, directly or indirectly, just for the heck of maintaing ethics, values and upholding patients’ interest?

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.