Addressing Prescription Drug Shortages
http://thedianerehmshow.org/shows/2011-11-02/addressing-prescription-drug-shortages
Critical shortages of medical drugs are becoming so common we’re facing a “public health crisis” according to some in the industry. So much so it prompted President Obama to issue an executive order aimed at easing the shortages. The concern is mostly over generic drugs given by injection. But within that area, the shortages are becoming acute and widespread. More than 180 drugs have been declared in short supply this year. Many of them are vital for treating childhood leukemia, and breast and colon cancer. Join us as we discuss the impact of the shortages and the government response.
Guests
Gardiner Harris
science reporter for The New York Times and author of the mystery novel "Hazard."
Sandra Kweder
deputy director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research
Dr. Christopher Lawlor
pediatric oncologist, Children's National Medical Center.
Heather Bresch
president, Mylan.
Comments
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In a free market manufacturers will struggle to provide plenty of the things people demand because adequate profit is guaranteed?
So, if we completely deregulate Big Pharma availability will improve and prices will optimize and balance out?
NO_O_O_O_OT!
(The problems of health care affordability, "intellectual property", reliable testing, taxpayer subsidy (corporate welfare), new drug sparcity and medical extortion would remain. The "free market" allows drug manufacturers to behave like pirates, and "money as free speech" allows them to be rewarded for such behaviors.)
Prior to commenting, I would encourage you to familiarize yourself with an issue. In this instance:
1. "Big Pharma" is not involved. They long ago exited these markets (generic injectables) as the margins are low and the manufacturing processes are complex and expensive.
2. The vast majority of these substances are made off-shore in India, China, the Middle East, etc., where lower costs allow for a profitable venture. This obviously increases the complexity of regulatory over-sight, e.g. FDA, supply chain issues, etc.
3. These products are enormously difficult to make, requiring multinational supply chains, sterile fermentation, sterile filling (often in isolator chambers due to the toxicity of the substances, e.g. oncology drugs), lyophilization, etc. It is an enormously complex house of cards, where one misstep affects all downstream processes.
4. Due to low margins and enormous costs associated with establishing and validating qualified and reliable manufacturing sites, these substances usually have only one or two sources. If one site gets a cold, the entire industry supply chain gets pneumonia (metaphor - work with me here).
This community is quick to embrace anti-corporate, anti-capitalist, hyperbole. In this instance, to do so is biased, wantonly ignorant, and just plain wrong.
For all of those who worried about the death panels and the government dertermining what treatment you could get under the health care bill, under this free market we get much worse. The big drug companies decide not to make a drug because it is generic and not as profitable as when it was under patent.
How many of us will die because we can't get a drug that could cure a condition that we develop. A very sad state of affairs in these United States.
thanks for covering this Diane! Why is this happening now for so many different drugs? Not just these injectibles that people are talking about. I have chronic migraines and the only medicine that has worked for me for many years is now unavailable - Midrin. My pharmacist said to just order from Canada...
Sounds like a great business opportunity for you. You should start a business with a mission to produce difficult products with high costs and low margins. Let me know how it goes trying to find investors.
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@jlynwood
Where's the "Like" button when we need it?
Actually, I'd love some shoeleather reporting on what drugs are "Big Pharma" and what aren't. When I'm in the hospital (a thankfully rare event) they don't tell me much about drug manufacturers and who makes what.
Big Pharma's image is about making me think they're an irreducible part of the lifesaving hospital experience. Staples likes to make me think they're an irreducible part of running and supplying my home office. But when I want to buy a ream of cheap paper, Staples doesn't show me the door.
Just another example of how the profit motive and healthcare are doomed to fail each other.
As a physician and anesthesiologist I have seen these critical drug shortages every year for many years. Does not the fact that less than a handful of generic manufacturers in the US make the vast majority of these drugs seem like a monopoly and make them "too big to fail"? We've seen this problem before and ultimately failure does occur. What proactive actions should be taken?
Dr. Bailey
The FDA allows something called "skip lot" testing which means that not each batch is tested to ensure that each batch of drugs is manufactured according to specifications. Drug components and drug manufacturing in Indian and especially China leaves patients vulnerable to bad drugs.
Ask the FDA staff how often India and Chinas' plants are inspected. It is NOT often enough to ensure integrity of drugs manufactured in these countries.
I am a clinical pharmacist at a large teaching medical center and these shortages are the worst that I have seen in my 27 years of practice. Whatever the problems are, I hope they will be solved ASAP. Just last night, I worked in the OR pharmacy and we are dangerously close to running out of Fentanyl, an often used narcotic pain medication. This is only one of many. We are lucky in that we have proactive inventory specialists who can garner adequate supplies BEFORE the inventory becomes critical. PLEASE resolve these manufacturing issues SOON, or patients will be suffering!
Generics are the same as original products and have to maintain the same specifications. True or False? There are gaps and loop-holes in production requirements allowed by the FDA. I used to run comparative tests. A major difference could often be found in toxicology (heavy metals) and general refinement of a product. Generics are simply more interested in profits than making medicine, but the entire industry is now contaminated. I saw the company I once worked for become a shadow of itself based on corporate decisions and bringing people into the company that had little interest in medicine. The FDA knows all too well how orphan drugs were originally maintained. I wouldn't want to put my life on the line with a generic....
Foreign manufacturers are rarely inspected because of budget constraints, funding and shortage of inspectors. It's like FAA inspections of foreign aircraft repair stations. China is trying hard to get approval to manufacture our drugs, and when they do it will be a disaster for our health care. Remember all the problems with tainted baby formula, dog food, dry wall, etc. The Chinese will do anything to bend the rules and make more profit at the expense of all our lives.
So, stopping and starting production capacity (and manipulating inventory) at will without informing customers or regulating agencies resembles electricity brokerage, "Smartest guys in the lab."
Quashers of free speech beware: I can comment when I wish and in the way I wish according to my understanding and the regulations of this site. Wanna try a general assembly?
Louie, Louie the corporate worshipper twists the truth much more pretzelly than I. My truth is demonstrably generic. His is a brand name and a bottom line. "Oh! It's so hard for me to make an aspirin in my little lab in the Chinese forest. Send more golden coins and hobbits to help me. Hurry, hurry captured American regulators!"
HEPARIN VERSUS LOVENOX!
The heparin shortage will force Doctors to prescribe Lovenox. It is a much more expensive similar medicine. Sabotage puts newer drug manufactures in a bad light.
Thanks, Becky Bertalan
Dr. Lawlor treated my son, Chris back in 2000-2002 at Children's Hospital in DC for Accute Myelogenous Leukemia. I just want to give a shout out to all the Dr.s and the most wonderful nurses there who live for making sure these children have access to the drugs they need, when they need them. They are doing wonderful things and we as a nation, need to continue to put pressure on the government to make sure these children have safe, effective drugs to fight off these terrible, horrible diseases and to make sure the drugs are approved for the use in children, as far too many children need these treatments now, not tomorrow. Great work and thank you for having this discussion.
I do not understand why the powers that be (in both in private and public sector) do not bring the manufacture of these medicines back to the United States.
I, personally do not trust the private, profit driven sector to do the right, responsible, humanitarian thing. They are driven by profit, and profit alone. Not much good comes from the extreme greed shown by these companies.
Obama is right on to try to solve some of this drug shortage crisis. We need to keep manufacturing in the United States for our own interests and to not be dependent on other countries for our health care. Quality control is not the same in China or India as we have seen in the past. The fact that the drugs are made in other countries is a breach of national security- we don't even make penicillin in the US anymore!
Our government has failed on many fronts, and this is just an example of another one. I agree with the other comment about not trusting the private sector to do the right thing all the time. They are there for profits, so the government needs to step in and provide incentives for the companies to keep making drugs here!
As Executive Director for the Oley Foundation, a national non-profit organization focusing on the issues and concerns of those who sustain themselves via intravenous or tube fed nutrition I'd like to call attention to the fact that the drug shortages have impacted this group of unique individuals. Their solutions are their "food" and many are being told that ingredients to compound their "meals" (solutions) are not available due to the current shortages. With no end in sight, one can only imagine their stress... especially those of the parents who cannot be certain that the ingredients necessary to "feed" their child and support normal growth will be available today, tomorrow or next month. To learn more enjoy a visit to www.oley.org or call 800.776.6539.
Diane asked what drugs are being affected, but none of the panelists mentioned an area that affects me personally: many of the components of Parenteral Nutrition are in short supply. There is a growing population of people who rely on IV infusions to meet their nutritional needs. This shortage is very scary for those who cannot eat or whose digestive system does not permit adequate absorption of nutrients. PN includes amino acids, lipids, vitamins and electrolytes. As a young woman, who is very frightened by the shortage, told me recently, "It's not like any of us can eat a cheeseburger or a salad".
Due to the shortage, I now infuse two IV bags over 12 hours, whereas previously I only had to infuse one bag for 9 hours.
Hi Dianne, thanks for tackling such a relevant topic. I am a pharmacist, previously worked in a drug company, so I have seen both sides of the industry. I understand that generic manufacturing has gone out of the US because of cost and profitability issues. However, I truly believe that FDA needs to mandate these foreign generic manufacturers to allow full access to their plants before they can market in the US. I think it is totally unacceptable that we still import drugs from China when FDA inspectors are not allowed to check their facilities. There are so many other countries in Asia and South America that will allow full access to their manufacturing plants that generic companies can utilize. Patient care and safety should come first and this is the ultimate raison d'être for FDA as a regulatory agency..
Pharma rips us off and then rakes in Billions, surely they can afford to build the new state of the art manufacturing facilities in the US that are needed to keep drug quality high. Create some jobs in the process. They would rather put us in crisis than do what they need to do.
Don't tell ME that "if not for the money, no one would do it" (think of Dr. Jonas Salk), and let me tell you that in my 21 years as a licensed nurse, in private I have heard countless decent, caring nurses' and doctors' frustrations at their restricted efforts, as they are not allowed to help their patients in any way that impedes profits. Seriously.
And to think, OUR government subsidizes ...CORN? Any decent, civilized society with the kind of resources held by this nation should be ashamed to be shortchanging the weakest of its citizens.
To those who loathe to see their tax dollars go to treat sick children when their children aren't, don't be so short-sighted. Any *THING* can happen to any *ONE* at any *TIME*, and believe me, before it's over, most of us get our turn to experience the "care" in the healthcare sysetm.
THIS is just one of the scenarios we were warned about when healthcare corporations set out to become the "The most PROFITABLE business in the history of world!" Google: "Birth of the HMO", QUICK, before they censor the internet (believe me, they're trying to-google: Protect IP-techdirt video) in corporate efforts to stifle every bit of truth that reveals their real incentives. If you only KNEW how much of your tax money is used for "private contracts" with friends of DC insiders, and other major financial "leaks", you'd fight like hell to get some of it reassigned to provide SOME benefit to those of us who actually *pay* our taxes. YES, it is expensive to provide the medicine to children with Leukemia, but really, in a nation that *CAN* afford it, but doesn't? If this doesn't shake people up and mobilize them to fight for positive change, it's a deeply tragic state of affairs.
Why CAN'T the govt. make/enforce a rule of co-operation w/conglomerates every yr to ensure supplies w/ keeping a certain amount of inventory of the most (of these crucial) drugs in supply ??? Also w/poor supply/regulation abroad, why aren't the pharma co's warned cited of the rules/laws ???
Read White Coat, Black Hat regarding the pharmaceutical industry, outsourced clinical trials, outsourced drug mfg, etc Can you REALLY trust medications when everything is outsourced and not under regulations? ANd the shortages of drugs will just make this worse.
yup, that sums it up: OUR government subsidizes ...CORN?
Every American should sit up and take notice that our manufacturing base has been destroyed by greedy management out to line their own pockets. Today I saw this IS a universal problem. Its not just the steel or auto industry, or aerospace, which at one point in this country were considered strategic industries required to defend the country, but its even our pharmaceutical industry thats required to keep us healthy. They have given it away also. When I heard that the last U.S plant producing antibiotics (like penecillin) in this country stopped manufacturing them in 2004, I could not believe it. Regulation of our plants with 2 year inspections, while not regulating import of foreign manufactured drugs is crazy. I'm sure American drug companies are making a fortune charging american prices for foreign produced goods. I wonder who paid off congress to make that happen? And why is it important to know where our food is produced, if we don't even know where our bactrim or insulin is made? Maybe its because if we knew we would be really upset. WE Need some patriots at the top of these companies not thieves.
One of the panelists mentioned that even drugs supposedly made in the US depend on active ingredients imported from China and India, which he described as strategic materials. That's the core of our national problems. Deliberate trade and tax policies have led 50,000 US manufacturing plants to shut down in ten years, with their jobs moved offshore with all the collateral damage that does to families and communities.
That's bad enough, but those same trade and tax policies mean that companies don't even try to make all kinds of strategic materials, whether drugs or electronics, in this country. I believe it was Nikita Khrushchev who said that capitalists would sell their adversaries the rope that hangs them. They didn't quite sell the rope, they gave it away so they could make themselves more money and hang the rest of us.
Comment by St. Louis was accurate - too bad he or she had to add the last political comment that only detracts from discussion of solutions.
I started my pharmaceutical career in regulatory affairs in the late 1980s at a generic manufacturing firm that made injectable syringes. They are very difficult and expensive to manufacture: clean rooms, constant monitoring for pyrogens; stability studies; and final inspection for particulates. The current shortages cannot be blamed on too much regulation - the regulations for safe manufacture have been the same for decades. The reason generics took off during the 1980s was because they are very profitable (clinical trials were not needed to establish bioequivalence); the regulations did not deter them - and the regulations are the same as they are today. Now I work for "branded" firms, who are regulated no differently than generic. I read the FDA site for warning letters to manufacturers and recalls (drugs, devices, foods) daily. The ones that raise my hair are the ones about plants overseas - like China. Those regulations keep us safe - I would not work in the pharma industry without these regulations.
So true! Google: Story of Stuff, FEC vs. Citizens United as a very simple explanation, even our kids can understand. Corporate Profits over EVERY other consideration could be the end of us if we don't get a handle on this. NAFTA has crippled us, but the Trans Pacific Partnership Obama signed a few weeks ago could be the final blow. It seems none of our votes matter, and that's when and if they haven't tricked people into voting against their own best interests.
If ONLY it were CORN that could save us! See "King Corn" , and "Food, Inc." if you haven't. It's so heavily subsidized (Corporate welfare again) that it is nearly free to produce. Great! Then they have to keep thinking up ways to use it, hence the most profitable sweetener in the history of the world! (HFCS) is in most all of our food, and all on its own, probably a huge factor in the soaring diabetes/obesity rates. If you see comforting science to the contrary, rest assured it’s financed by HFCS makers, but there is NO agenda in admitting its harm, so I trust this science. It's even in nearly everything; name brand yogurts, ketchup and yes, even BREAD. Makers of HFCS are fighting to get to change its name, so more will consume HFCS unwittingly.
*It seems I'm off topic, but this, in the bigger picture is an example of how this whole thing is set up.
We MUST get our nation back from this corporate death grip on our lives! Watch how ads pit citizen against citizen. THIS is their Second most powerful weapon after the billion$ thrown at our law makers! Politicians take aim at anything that uses tax dollars to benefit citizens, and divide & conquer us by pretending that if only your tax dollars didn't go to programs/services for elderly, disabled and kids, you'd be taxed LESS. It NEVER happens. They may get you to vote to cut social spending, but after that, THEY, not YOU get a bigger piece of the pie, and now you have even more people dying for lack of access to adequate food and safe medicine.