Propofol -- one of the drugs that led to Michael Jackson's untimely death -- is a short-acting, intravenously administered hypnotic agent. Known in some circles as "Milk of Amnesia," its uses include the induction and maintenance of general anesthesia, sedation for mechanically-ventilated patients, and procedural sedation. Propofol -- and its generic equivalents -- has been widely and successfully administered in hospital operating rooms around the world for nearly 30 years. And, as of June 4, 2010, Teva Pharmaceuticals, the Israeli-based firm that was the major supplier of Propofol, no longer manufactures it. Today, it is almost impossible to find.
Where has all the Propofol gone?
And while we're at it, where has all the Doxil, Adderall, Mitomycin, Morphine Sulphate, Avalide, Ondansetron, Succinylcholine, Dextrose, B-12 and more than 200 others medicines gone? Shockingly, between 2006 and 2010, drug shortages increased by more than 200%\
according to a Government Accountability Office Report released late last month. Many of the drugs declared "MIA" are critical chemotherapeutics; intravenously infused medicaments and "cocktails" that often mean the difference between remission and metastasis -- between life and death. Some of shorted meds -- though far less exotic -- are just as critical to the health and well-being of patients in need: things as basic as injectable cobalamin (vitamin B-12) and Tylenol 1 (the 325 mg version). Although a lack of injectable B-12 might not seem as critical as a dearth of Propofol or Doxil (a chemotherapeutic drug used in the treatment of breast cancer), it can be for the patient in need; severe B-12 deficiency can lead to irreversible damage, especially to the brain and nervous system.
When and if a supply of these drugs can be located, it is at a cost; there are reports of drugs which distributors sold just two years ago for $25.00 per dose, now going for as much as $1,200 per dose on the "Grey Market." And this phenomenon is not confined to certain states or regions; it's happening all over the United States. Large, well-heeled establishments like the Mayo Clinic, Cleveland Clinic and Vanderbilt University Medical Center at least have the possibility of purchasing critical medications -- at monstrously inflated prices -- because they have the resources to order in great quantity. But one should keep in mind that there are just as many patients whose lives depend on receiving chemotherapeutic drug protocols who live in small towns and are served by small hospitals that don't buy in quantity and cannot afford to pay hyper-inflated prices. Sometimes, when a drug that a patient tolerates well becomes unavailable, the doctor will prescribe an alternative -- which frequently the patient cannot tolerate. With some medical conditions, an interruption in treatment of a month, even a week, can be disastrous . . . even deadly.
The question is not only "Where has all the Propofol gone?" but "What has led to its scarcity?"
It all depends on who you ask, what ones starting point might be . . . even what axe they may be grinding. Make no mistake about it: the scarcity of pharmaceuticals is an issue and a problem for both Democrats and Republicans, ultra-conservatives and ultra-progressives. Anyone, regardless of his or her political philosophy, can contract cancer or Crohn's Disease, require surgery or suffer from a thousand-and-one life-threatening ailments. And yet, when it comes to analyzing the current situation, politics and point of view do count for something.
At base, market forces have a lot to do with the scarcity of drugs. The prices we pay for pharmaceuticals in the United States are far higher than those paid by the citizens of any other country in the world. In large measure this is why the pharmaceutical industry has for years been the most profitable of all businesses in the U.S. According to the annual Forbes 500 survey , the American pharmaceutical industry tops the list of all industries with a return of 17% on investment. And although the cost of manufacturing a new drug is relatively low, the cost of inventing and then patenting a new drug is relatively high. Drug manufacturers have always claimed that the high cost of pharmaceuticals is due to this latter issue. Then too, much of the cost of bringing a new drug to market can be found in advertising costs; ever notice all those commercials telling us to tell our physician that we want them to prescribe drug "x" or "y" for condition "a" or "b?" Silly me; I thought it worked the other way around; that the doctor did the suggesting and prescribing to me, and not I to her . . .
Many, many pharmaceutical giants have seen their patents lapse and other companies manufacture, then market, generic versions of their creations. Generally speaking, when a drug goes off patent and becomes generic, the price drops precipitously; the companies making them are in the business of gaining as much market share as possible. Some place blame on the Medicare Prescription Drug Improvement and Modernization Act (H.R. 1) which Congress passed and President George W. Bush signed into law on December 8, 2003. This act limits Medicare payment for physician-administered drugs to average sales price plus a 6% administrative fee, which manufacturers claim has limited profit margins and thus their ability to maintain and upgrade their facilities. And despite the fact that H.R. 1 provides for an analysis of average sales prices twice a year, it still means that the profit to be made on these generics is guaranteed to rise at a fairly slow pace. Many companies have concluded that if drug "x" can't bring in more than 6% profit above cost, they simply will discontinue its manufacture.
Another factor is the drug distribution system itself. Physicians face pressure from health insurers to obtain the best prices for prescription drugs through multiple distributors. However, as noted above, distributors tend to provide the best prices and most stable supply to high-volume purchasers. Then too, according to information provided by IMS Institute for Healthcare Informatics, most of the nearly 170 prescription drugs in a shortage status as of October 2011 were offered by a single supplier or a small number (under 4) of firms.
Some claim the problem has been exacerbated by tighter Food and Drug Administration (FDA) enforcement of drug manufacturing standards. (According to public records, over the past 2 years, the FDA expedited more than 300 industry applications for new or updated manufacturing facilities. ) This past October, President Obama signed an executive order requiring the FDA to expedite regulatory review of drug manufacturers and investigate price gouging. At the same time, the White House announced that they would immediately begin requiring some drug manufacturers to report production interruptions to the FDA. The manufacturers that have to report to the FDA are those drug manufacturers that have no generic equivalent and are critical to maintaining life. There are currently two pieces of legislation making their way through Congress calling for advanced warning of impending drug shortages and more FDA action. But passage is both uncertain and a long way off. For now, drug distributors would appear to be in the driver's seat.
Today, a majority of the shorted meds are being manufactured overseas -- in China, South America, Eastern Europe and Israel. The FDA simply does not have the budget or manpower to inspect these foreign manufacturing plants. As a result, there are a lot of pharmaceuticals on the market that do not meet American safety standards -- another cause of shortages.
That the country which prides itself on having "the best healthcare on the planet" should have these problems -- drugs shortages, an unscrupulous "grey market" charging sky-high prices for life-saving meds, and a fast-declining manufacturing base -- is unconscionable. That no other industrialized country suffers from a similar set of problems likely shows that we do not, in fact have "the best healthcare on the planet." To my way of thinking, many of these problems would be alleviated by going to a single-payer system; one that recognizes that although industries -- especially those that employ more lobbyists than any other on the planet -- have a constitutional right to make a reasonable profit, human beings have a God-given right to live.
If Michael Jackson's doctor could get his hands on Propofol why can't my doctor at the Cleveland Clinic?
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