All opinions are my own.

Friday, October 2, 2015

Is Pharma’s Goal to Serve Patients Per Billion or Million?

In the pharmaceutical world, week of September 21, 2015 was interesting. Martin Shkreli (1) of Turing Pharmaceuticals raised the price of an old drug (Daraprim) from $13.50 to $750.00 per tablet overnight. Suddenly the high price move is being abhorred. Shkreli’s move and rationale has been equated to greed and arrogance. This has led to all kinds of pro and con comments in press (2,3,4,5,6). Even politicians, who generally are significantly influenced by the pharma lobby jumped out and called for price restraint (7). His explanation for the price increase included from need to make money irrespective of the past selling price to pay for his acquisition of the drug license, lack of customer service and need to pay for high R&D costs to customer service (8). Most likely Shkreli has no clue of the manufacturing cost and what is involved. Having been around for the last sixty years, no R&D is involved. I am not sure what kind of customer service was missing.

Question “why suddenly drug prices are being increased by high multiples?” Dr. Peter B. Bach (9) from Sloan Kettering makes interesting points “To criticize drug pricing is to raise a more difficult question: Is any price too high to save or extend a life? But in the U.S., prices are rising not because they must, but because they can. No entity holds them down. Instead, state and federal regulations require nearly every insurer to provide access to all cancer drugs, which means the companies can charge what they like. Doctors, meanwhile, are trained not to consider the cost of a treatment when making medication choices.” He makes very constructive suggestion on drug pricing “If we want innovation, and we certainly do, the solution to affording it lies in paying only for its value.”

Recently other companies have joined to increase their prices (7,10). Suggested global price variability ($900 to $30,000) for six month Tuberculosis course is astounding (11). There have been other price increases over the years but they were not publicized.   

Most of the pharma conversation in press is generally about preservation/increase of revenue, profits and justification of high R&D costs to develop new drugs even if they were for less than 100,000 patients (about 14 patients per million) worldwide. Drug with sales of one billion dollars per year is considered a blockbuster success even if there are 10,000 patients worldwide (one to two patients per million) paying $100,000 per patient.

Like in every business, pharma also has R&D and manufacturing costs. R&D costs are considered the untouchables. No one wants to accept any other explanation of these high costs as the press information, even if it is wrong, is considered sacrosanct. Discussion of inefficiencies in R&D is off-limits from any conversation.

At times pharma’s high cost are blamed on manufacturing and regulations (12). There is no mention of any effort to lower manufacturing costs or marketing costs. Very few understand the cost breakdown. This is due to lack of understanding of how to calculate the factory costs of the APIs and their formulations. Every inefficiency cost of manufacturing process is passed on to the patients. Patients pay, as they want to live.  

Irony is that in the last few years pharma companies have not developed many drugs for a large patient base (e.g. more than five million) worldwide. Whatever has been developed, as stated above, is for small patient base. They are expensive and covered by mutually subsidized healthcare systems or pay from their own pocket. Some physicians and pharmacy benefit managers are balking to prescribe or cover these drugs (13). Price of Hepatitis C virus has been questioned.

In the United States, due to political influence, Medicare cannot negotiate prices. In many other countries, there are price controls and negotiated pricing with national healthcare purchasing. Pharma companies definitely do not like that. Generics love the high prices they can get for their products in the developed countries even after repeated product quality mishaps.

There is no question that innovation is needed in pharmaceuticals. However, the question is “are these innovations for the selected elite?”

Drugs are supposed to be beneficial for masses. However, with current drug prices, pharma companies while making profits are driving families to bankruptcies. High prices are definitely not giving pharma a good name. Is this the legacy pharmaceutical companies want? I do not believe so.  

It is my conjecture that for pharma to move from about 10-15 patients per million (=about 85,000 patients out of 7.2 billion global population) and high priced drugs to 7,000 patients per million or higher number (=about 5 million patients out of 7.2 billion) and affordable drugs, significant effort would be needed to discover drugs that are highly effective (no me-too) for common diseases. If such drugs are discovered they would also be an opportunity for significant manufacturing technology innovations.

Pharma (14) might achieve its projected $1.3 trillion sales in the next few years but it would have to pick its patient base. Would it be 10-15 patients per million, mostly in the developed countries or 7,000 patients per million worldwide? Do you think the later would happen?  

Girish Malhotra, PE
EPCOT International

1.     My Lunch With Shkreli: What We Should Learn From Pharma's Latest Monster: http://www.forbes.com/sites/matthewherper/2015/09/24/my-lunch-with-shkreli-what-we-should-learn-from-pharmas-latest-monster/ accessed September 26, 2015
2.     Turing to Cut Price of Drug Daraprim After Increase Sparks Outcry: http://www.wsj.com/articles/turing-to-cut-price-of-drug-daraprim-after-increase-sparks-outcry-1442970732 accessed September 26, 2015
3.     The Assault on Drug Innovation: http://www.wsj.com/articles/the-assault-on-drug-innovation-1442964103#livefyre-comment, accessed September 26, 2015
4.     New Weapon in Push to Lower U.S. Biotech Drug Prices: http://www.wsj.com/articles/new-weapon-in-push-to-lower-u-s-biotech-drug-prices-1442965627?tesla=y accessed September 26, 2015
5.     What Cancer Doctors Don’t Know About Cancer Drugs: http://www.wsj.com/articles/what-cancer-doctors-dont-know-about-cancer-drugs-1442961874 accessed September 26, 2015
6.     Biotech exec Martin Shkreli has history of tough tactics: https://www.bostonglobe.com/business/2015/09/25/how-martin-shkreli-biotech-pariah-put-cancer-patients-risk/fxjUV8alj28LESmmOF7IbO/story.html accessed September 26, 2015
7.     Lawmakers Seek Answers on Valeant’s Price Increases http://www.wsj.com/articles/congressional-democrats-seek-subpoena-of-valeant-over-drug-prices-1443468385 accessed September 29, 2015
8.     Drug Goes From $13.50 to $750 Overnight: http://www.bloomberg.com/news/videos/2015-09-21/why-turing-increased-price-of-daraprim-over-500- accessed September 26, 2015
9.     Bach, Peter M. Seeking a cure for drug-price insanity, Fortune Magazine http://fortune.com/2015/09/17/rising-drug-prices/ Accessed September 25, 2015
10.  Lupin diabetes drug price up by 200% in US http://www.business-standard.com/article/companies/lupin-diabetes-drug-price-up-by-200-in-us-115092400935_1.html accessed September 29, 2015
11.  Dishman to supply API for Janssen Pharma's TB drug Sirturo: http://www.business-standard.com/content/b2b-pharma/dishman-to-supply-api-for-janssen-pharma-s-tb-drug-sirturo-115092900626_1.html?src=email accessed September 29, 2015
12.  Gottlieb, Scott: A Clintonian Misdirection on Drug Prices, http://www.wsj.com/articles/a-clintonian-misdirection-on-drug-prices-1443568738 Accessed September 30, 2015
13.  Top U.S. doctors say pricey cholesterol drugs best for limited group: http://www.reuters.com/article/2015/09/24/us-usa-healthcare-cholesterol-idUSKCN0RO2DD20150924 accessed September 29, 2015

14.  Malhotra, Girish: Manufacturing technologies and their part, Chemica-Oggi-Chemistry Today, Vol. 33(5), pg.28-31, September/October 2015

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