PDA

View Full Version : Morphine shortage




tod evans
11-17-2012, 11:20 AM
Drug Shortages Persist in U.S., Harming Care

http://www.nytimes.com/2012/11/17/business/drug-shortages-are-becoming-persistent-in-us.html?hp&_r=0


Paul Davis, the chief of a rural ambulance squad in southern Ohio, was down to his last vial of morphine earlier this fall when a woman with a broken leg needed a ride to the hospital.

The trip was 30 minutes, and the patient was in pain. But because of a nationwide shortage, his morphine supply had dwindled from four doses to just one, presenting Mr. Davis with a stark quandary. Should he treat the woman, who was clearly suffering? Or should he save it for a patient who might need it more?

In the end, he opted not to give her the morphine, a decision that haunts him still. “I just feel like I’m not doing my job,” said Mr. Davis, who is chief of the rescue squad in Vernon, Ohio. He has since refilled his supply. “I shouldn’t have to make those kinds of decisions.”
From rural ambulance squads to prestigious hospitals, health care workers are struggling to keep vital medicines in stock because of a drug shortage crisis that is proving to be stubbornly difficult to fix. Rationing is just one example of the extraordinary lengths being taken to address the shortage, which health care workers say has ceased to be a temporary emergency and is now a fact of life. In desperation, they are resorting to treating patients with less effective alternative medicines and using expired drugs. The Cleveland Clinic has hired a pharmacist whose only job is to track down hard-to-find drugs.

Origanalist
11-17-2012, 11:34 AM
Don't break a leg. :( I had no idea this was going on.

BenIsForRon
11-17-2012, 11:36 AM
Farmers in Afghanistan could solve this pretty quickly.

tod evans
11-17-2012, 12:06 PM
Farmers in Afghanistan could solve this pretty quickly.

They've been trying, but our government is doing what it does...

tod evans
11-17-2012, 12:15 PM
Cancer patients and those in debilitating pain who are not relying on the government for their pain relief medication have discovered heroin.

So realistically government is curtailing the supply of "legal" narcotics and then ramping up enforcement of "illegal" ones at the expense of those in pain...

But that's okay, it's for the kids....:mad:

thoughtomator
11-17-2012, 12:27 PM
Farmers in Afghanistan could solve this pretty quickly.

Farmers in Iowa could solve this pretty quickly, if our government were not psycopathically authoritarian.

Brian4Liberty
11-17-2012, 12:36 PM
Hmmm. Morphine is the number one "legitimate" euthanasia drug in the US. Have they been using more of it lately?

QuickZ06
11-17-2012, 12:38 PM
I wish the fruits of the land would provided us with some natural pain medicines, that way the government does not have to shove all these pills down our throats :rolleyes:

donnay
11-17-2012, 12:39 PM
I do not know about any of you, but I started seeing and alarming trend a few years ago...giving morphine for the littlest of things. For example: Women in labor--normal labor, not Cesarian or other complications.

I remember a time when morphine was only given to people who were on their way out, to give them comfort from the pain. Now it appears they are giving people morphine for migraines, tooth aches and childbirth. Which I thought then, was a dangerous road to be on.

tod evans
11-17-2012, 01:01 PM
I think doctors and dentists are far more qualified to determine who needs which drug when than any government official.

angelatc
11-17-2012, 01:11 PM
Donnay - this has you written all over it:
Regardless of the cause, the drug shortage has forced the F.D.A. to make some tough choices, including allowing manufacturers to sell drugs that, if it were not for the crisis, most likely would have been recalled. Last year, for example, the agency allowed the manufacturer American Regent to sell a drug used during chemotherapy (http://topics.nytimes.com/top/news/health/diseasesconditionsandhealthtopics/chemotherapy/index.html?inline=nyt-classifier) that was found to contain glass particles. Doctors and nurses were instructed to filter the drug (http://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=4&ved=0CEQQFjAD&url=http%3A%2F%2Fwww.americanregent.com%2Fdocument s%2Fnews%2FwouIRLzwvIs%3D.pdf&ei=KsWjUOWaEsqu0AH0kYDoCA&usg=AFQjCNGqvwYBeZS7sKyGw56fLD0fVPr8xg&cad=rja), sodium thiosulfate, before administering it to patients.

Anti Federalist
11-17-2012, 01:18 PM
Farmers in Iowa could solve this pretty quickly, if our government were not psycopathically authoritarian.

This +rep.

Think about that.

Government, in its never ending quest for more power and control, subjects sick and injured people to excruciating pain, when relief is a simple plant extract away.

That is the very definition of "psychopathic".

presence
11-17-2012, 01:21 PM
Farmers in Iowa could solve this pretty quickly, if our government were not psycopathically authoritarian.

THIS ^^^


Just curious... does anyone know where we are importing our opium products from?

Anti Federalist
11-17-2012, 01:23 PM
Not a War on Patients

Tuesday, November 13th, 2012

http://www.theagitator.com/2012/11/13/not-a-war-on-patients-3/

I still get a couple emails like this each week in response to the painkiller series I wrote for Huffington Post back in March:


My husband died 4 years ago from a massive cerebral hemorrhage. He had multiple health problems but the worst one was a severely degenerative disc disease. Because he was on Plavix he was not a candidate for surgery. He took 80 Oxycontin daily for 3 years and 9 months prior to his death. But then the doctor at the pain management clinic he went to regularly informed him that the clinic was quitting prescribing oxycontin. In those last three months of his life he was . . . in agony. All he wanted to do was be able to walk across the living room to get to his potty chair without pain. He wanted to sleep but couldn’t because of the pain. He was incapacitated by the pain, and not because of drug abuse, but because the doctors at the clinic were afraid of losing their licenses. If I had known he was going to die, I would have found some way to get the Oxycontin for him. He was never high or stoned. He just wanted to be free of pain. As much as I miss Roger, I am glad he is now pain free.

But remember, this federal campaign against opiods is not a war on pain patients.

I know because the drug czar himself has assured me that patients like Roger have never had any problem getting the medication they need.

Anti Federalist
11-17-2012, 01:25 PM
#1 | Joshua | November 13th, 2012 at 11:06 pm
Let’s not forget that the same type of person who supports an aggressive war on drugs generally also supports using torture in the war on terror. To put it another way, they have no problem inflicting extreme pain on a person they don’t know in order to achieve their aim.

///

kathy88
11-17-2012, 01:26 PM
If they want more narcotics they should just visit my county. 85% of our welfare folk get monthly scripts and sell them for cash if they aren't addicted themselves. I'm sure there's extra.

tangent4ronpaul
11-17-2012, 07:24 PM
Why gosh!, who woulda thunk that the gubmint would be responsible for the shortages...

FDA’s Contribution to the Drug Shortage Crisis

http://oversight.house.gov/wp-content/uploads/2012/06/6-15-2012-Report-FDAs-Contribution-to-the-Drug-Shortage-Crisis.pdf

information obtained by the Committee on Oversight and Government Reform shows that the crisis was largely sparked by actions of the Food and Drug Administration (FDA). The Committee has learned that FDA regulatory activity has effectively shut down 30% of the total manufacturing capacity at four of America’s largest producers of generic injectable medications: Bedford Laboratories, Hospira Pharmaceuticals, Sandoz Pharmaceuticals, and Teva Pharmaceuticals. Of the 219 drugs listed on the American Society of Health System Pharmacists (ASHSP) shortage list as of February 21, 2012, at least 128 – 58% of the drugs on the shortage list – were produced by at least one facility undergoing FDA remediation.

...

Among shuttered manufacturing lines that occurred over the previous two years, the committee’s review did not find any instances where the shutdown was associated with reports of drugs harming customers.
When problems that do not pose an immediate threat to public safety are detected, directing facilities to make targeted improvements under close supervision of the FDA can be a more appropriate response than actions that lead companies to shut down manufacturing lines. While such a response may place inconvenient burdens on the FDA’s bureaucracy, greater use of such a targeted approach would have significantly diminished the public health crisis the country is facing from the abundant number of drug shortages. It is noteworthy, however, that the overall damage inflicted by the FDA’s decisions to shutter manufacturing lines may extend well beyond the current drug shortage crisis. The shortages of generic injectable drugs are only the most visible result thus far of the FDA’s stepped up enforcement activities.
While FDA actions over the past several years are the primary reason for the severity of the drug shortage crisis, the Committee also found that growing market concentration over the past decade laid the groundwork for the crisis. One contributing factor to the growing market concentration is a provision of the Medicare Modernization Act (MMA) which dramatically reduced the prices paid by Medicare for many generic injectable medications, particularly older generics. Manufacturers are reluctant to raise prices above what Medicare reimburses providers who administer them. As a result, the Committee has learned that manufacturers are losing money producing generic injectable oncology drugs. When manufacturers lose money on a product, they are incentivized to switch production away from that product. Therefore, it is not surprising that many of the drugs on the shortage list are generic oncology drugs. A recent economics research paper found that drugs more affected by the MMA are much more likely to be in short supply than drugs less affected by the MMA.
Group purchasing organizations (GPOs) have also contributed to a market structure that makes shortages more likely. GPOs, which emerged as a mechanism for providers to increase their buying power, assemble large networks of hospitals and clinics who agree to purchase drugs through a GPO. GPO contracts, which are structured to take advantage of large economies of scale in drug production, result in only a few large manufacturers producing each generic injectable medication. Because of intense manufacturer competition to win GPO contracts, prices are driven down – the intended goal. As a consequence, however, companies that cannot produce a drug at large enough output levels to take advantage of the economies of scale – often because they lack the guaranteed source of demand that GPOs provide – will stop producing the drug or will neglect to enter the market.
Largely because of GPO contracting and the MMA’s impact on changing Medicare’s reimbursement formula for injectable medications, individual generic injectable drugs are being produced by at most three companies. In 2010, 90% of generic injectable oncology drugs were produced by three or fewer manufacturers. In such a tight oligopoly, the temporary closure of a significant number of the production lines in one or two manufacturers’ facilities makes shortages much more likely.
Key Findings:
 Information obtained by the Committee demonstrates the widespread shortages of generic injectable medications are due to two main factors. The first is growing market concentration over the past decade, which was accelerated by a provision in the Medicare Modernization Act (MMA). The second is increased FDA enforcement and regulation, which has shut down a substantial amount of manufacturing capacity.
 In 2009, Margaret Hamburg became FDA Commissioner. Between 2009 and 2010, the number of warning letters sent by the agency increased 42%. Between 2010 and 2011, the number of warning letters sent by the FDA increased an additional 156%. In many cases, warning letters have resulted in companies agreeing to take manufacturing off-line to address FDA criticisms.
 In response to FDA prodding, companies producing generic injectable drugs have taken their manufacturing off-line simultaneous to other generic competitors also going off-line. These simultaneous shut downs diminish the ability of competitors to offset shortages with increased production. Prior to these actions, Bedford Laboratories, Hospira Pharmaceuticals, Sandoz Pharmaceuticals, and Teva Pharmaceuticals were producing nearly one billion units of generic injectable products per year. Facilities at these companies are currently operating at about 700 million units per year, a 30% decrease in manufacturing capacity at America’s primary production facilities for generic injectable drugs. This decrease is a massive reduction in the industries’ capacity to supply the nation with injectable medications. The Committee could not find any evidence that any of the products produced at the facilities undergoing remediation had harmed anyone.
 Of the 219 drugs listed on the American Society of Health System Pharmacists (ASHSP) shortage list as of February 21, 2012, at least 128 – 58% of the drugs on the shortage list – were produced by at least one facility undergoing FDA remediation. Based upon the Committee’s investigation, it is clear that over the past three years the FDA has failed to protect adequate drug supply in efforts to remedy manufacturer problems.
 The Medicare Modernization Act (MMA) changed the reimbursement rate for injectable drugs delivered in outpatient settings and capped the growth rate in Medicare’s reimbursement paid to providers for administering these drugs. The impact of the MMA’s pricing changes has been to dramatically reduce the price of older, generic drugs administered in non-hospital settings. For example, Carboplatin, Ondansetron, and Irinotecan, three chemotherapy drugs, experienced price declines of approximately 90% in just their first year off patent. The prices for these drugs have not risen despite each of them being in shortage.
 The Committee asked America’s largest manufacturers of generic injectable medications whether they were losing money on oncology drugs, which tend to be administered in non-hospital settings. Most of the companies indicated they were producing several oncology drugs at a loss. For example, one company responded that it is producing about three-quarters of its nearly two dozen oncology drugs at a loss. Significant capacity constraints and the negative margins also contribute to generic oncology drug shortages.
 The Medicare Modernization Act (MMA) had the large and negative unintended consequence of increasing concentration in the generic injectable drug market and reducing company incentives to invest in upgrading manufacturing capabilities for generic injectable drugs.

=========

WOW! - we could kill off a bunch of those non-productive old geezers by creating "unintended" drug shortages of cancer drugs! That would be a real budget saver! :rolleyes:

-t

paulbot24
11-17-2012, 07:32 PM
A morphine shortage? This might be the first ever recorded shortage of anything that doesn't make the cover of Time magazine to scare us all into running around in circles and saying "The government should do something about this!"

Tudo
11-17-2012, 07:41 PM
Sometimes the supplies of percocet and other opiods in sw fla are non existent. I'm a chronic pain patient and sometimes they don't have ANY!. This in a state where cannabis is a felony.

Pretty soon it may be ceeya bye bye fla.

AGRP
11-17-2012, 07:49 PM
Opioids are for street junkies. Ban them all.

tod evans
11-17-2012, 07:57 PM
Opioids are for street junkies. Ban them all.

Absolute total and utter bullshit!

There's a reason every medic in the US carries ONLY morphine onto the battlefield, it fucking works!

And yes I have the years and 1st hand experience to make that statement..

Anti Federalist
11-17-2012, 07:58 PM
Opioids are for street junkies. Ban them all.

You need to use /s/

Otherwise, people may think you are serious.

osan
11-17-2012, 08:19 PM
Cancer patients and those in debilitating pain who are not relying on the government for their pain relief medication have discovered heroin.

So realistically government is curtailing the supply of "legal" narcotics and then ramping up enforcement of "illegal" ones at the expense of those in pain...

But that's okay, it's for the kids....:mad:

I will never forget when I heard someone (do recall who... methinks some medical official but do not quote me on it) justify the denial of heroin and similar drugs to terminal cancer patients who were in blind agony on the grounds that they "might become addicted".

Clearly I am just a man because no matter how strongly I believe in and advocate for the respect of human rights, I cannot always escape the nearly overwhelming urge to beat a specific person savagely with a bat because their shrieking, teeth gnashing stupidity should be met with nothing less.

tangent4ronpaul
11-17-2012, 08:21 PM
more:

drug shortages are causing them to change standard practices, often at much higher cost as name-brand drugs are substituted for generics.10 According to Dr. Ezekiel Emanuel, an oncologist, former advisor to President Obama, and professor of health policy at the University of Pennsylvania, “Most of these drugs have no substitutes, but, crazy as it seems, in some cases these shortages are forcing doctors to use brand-name drugs at more than 100 times the cost.”11

II. Economics of Shortages
Normal Market Forces Prevent Shortages
Why can milk always be found at the grocery store and fuel is always available at the gas station, but scores of critical drugs are now unavailable to people who need them? In a well-functioning market, shortages are virtually nonexistent; and when shortages appear, they are resolved quickly. Basic economic theory shows that when a product becomes more scarce (either because supply has decreased, demand has increased, or some combination of the two), its price rises. The higher price provides an incentive for both consumers and suppliers. The higher price encourages consumers to cut back on consumption of the product and look for substitutes, and the higher price encourages suppliers to increase production since doing so will increase their profits. Some combination of increased production and tempered demand bring supply and demand back into balance.
Many of the drugs in shortage are critical for patients and lack adequate substitutes. Patient demand for critical drugs is not going to be significantly tempered by higher prices. This is particularly true since abundant third party payment of health care expenses means most patients do not actually experience the direct impact of rising prices. Therefore, the key question to answer with the current drug shortage crisis is what is limiting suppliers from producing enough of the critical drugs needed to satisfy patient demand.
Government Price Controls and Shortages
Economic theory suggests that the first place to look when product shortages persist is for the presence of government price controls.13 Price ceilings, maximum prices enforced by federal or state law, represent barriers to price flexibility. Price ceilings effectively prohibit prices from
adjusting to the levels where consumer demand is tempered and suppliers are encouraged to increase production. As a result, supply and demand are not balance. Perhaps the most famous result from price ceilings in U.S. history is the presence of gas lines in the 1970s.14 An important economic truth is that while large government price ceilings hold down the money price, the total price, which includes the cost of waiting time and other inefficient rationing mechanisms, actually increases. Economists have shown that the large social welfare loss from this type of rationing far exceeds the benefit some consumers receive from artificially low prices.15 Clearly, rationing critical drugs through the use of waiting lists that can take months or years to clear is far more inefficient than somewhat higher drug prices.
Regulation and Shortages
Economic theory also shows that regulatory policy can play a powerful role in the overall amount of a production. For example, while regulation can provide certain benefits, regulation always produces corresponding costs. When industries confront a regulatory onslaught, the industries’ costs rise. This means the industry must produce less of their product at a given price. If prices are constrained from rising, shortages can develop. In theory, regulations can also directly restrict supply through regulatory injunctions, which effectively shut down facilities.

...

GPOs often provide suppliers with a preferred status or even an exclusive right to sell a particular product. If a manufacturer is not supplying any of the GPOs, but particularly the larger GPOs, with a particular product, much of the market is off limits. Since GPOs typically only offer preferred status to one manufacturer of a particular generic drug, and hospitals can be penalized for purchasing a significant amount of product from suppliers not affiliated with a GPO, the GPO structure reduces the number of manufacturers producing each generic drug.
Another problem is that GPO contracts contain clauses that limit price flexibility. According to a report by the Health and Human Services Office of the Secretary for Planning and Evaluation:
GPO contracts are generally in place for years and typically include price adjustment clauses. If a GPO is offered a lower price by a competing manufacturer, the original contracted manufacturer has a right of first refusal to match the new price. GPO contracts also typically include “failure to supply” clauses. These clauses generally require the manufacturer to reimburse the GPO for the price difference between the negotiated price and purchased price.20
Since GPO contracts typically last three years, prices are prevented from making necessary adjustment to provide supplier with market information and with the incentive to switch production from drugs with less demand to drugs with greater demand. Once it is apparent that a drug is in shortage, GPOs go to great lengths to obtain the drug. However, the market-created GPO structure has created a climate that makes drug shortages more likely by reducing the number of manufacturers of each generic injectable medication. While it may not generally be a large problem to have only a few producers of each generic injectable medication, it becomes a problem when one, two, or even three of the producers of a given drug have manufacturing problems at the same time.

Legislative-created Factors
The Medicare Modernization Act (MMA), signed into law in 2003 by President Bush, has also reduced the number of suppliers of generic injectable medications. While the MMA is best known as adding a prescription drug benefit to the Medicare program, the MMA also changed the reimbursement rate for injectable drugs delivered in outpatient settings and capped the growth rate in Medicare’s reimbursement paid to providers for administering these drugs. Before MMA, injectable drugs were reimbursed as a percentage of the drug’s average wholesale price (AWP). AWP, however, was not a transparent way to understand the actual cost of producing these medicines. According to Dr. Ezekial Emanuel, an oncologist, former advisor to President Obama, and professor of health policy at the University of Pennsylvania, AWP was “a license to steal” against taxpayers because it was so inflated.21 MMA changed the law so that drugs delivered in the outpatient setting became reimbursed as a percentage of the average selling price (ASP)22 plus six percent. Moreover, the MMA limited increases in ASP to six percent semi-annually.
The ASP for name-brand drugs – drugs with patent protection – is relatively high since there is a single producer with considerable pricing power. Since companies producing name-brand drugs have a strong incentive to produce enough of the product to satisfy market demand, almost no name-brand drugs appear on the drug shortage list. When a drug comes off patent, the law allows one generic company to enter the market for a 180-day exclusivity period.23 With only two manufacturers – the original manufacturer and the new entrant – the ASP is still relatively high, so producers have an incentive to continue producing these drugs. Moreover, because the company that gains the 180-day exclusivity period receives a temporary windfall profit, companies compete strongly to be the first generic producer.
After the 180-day exclusivity period, the market opens up for other entrants. Prices are driven down by market forces (competition) and expanded rebates and discounts given to the GPOs in an attempt to increase market share. According to Dr. Emanuel, “In the first two or three years after a cancer drug goes generic, its price can drop by as much as 90% as manufacturers compete for market share.… The low profit margins mean that manufacturers face a hard choice: lose money producing a lifesaving drug or switch limited production capacity to a more lucrative drug.”24 The figures on the next page demonstrate how quickly prices can decline when injectable drugs come off patent. Carboplatin, a chemotherapy drug primarily used to treat ovarian, lung, head, and neck cancers, came off patent in October 2004. Ondansetron, a drug used to prevent nausea and vomiting caused by chemotherapy, came off patent in December 2006. Irinotecan, a chemotherapy drug used to treat colon and rectal cancer, came off patent in February 2008. In the first year off patent, the prices of these three drugs declined 86%, 93%, and 86% respectively. Although falling prices are generally a positive development, problems arise if prices are not subsequently allowed to adjust to changing market conditions.

Under normal market conditions, if a drug’s price has been driven so low that manufacturers exit the market and switch to manufacturing other products, the drug’s price would start to rise. The price increase would encourage other manufacturers to enter the market. However, since the MMA restricts price increases to six percent semi-annually and these increases are on top of very low prices, the increases do little to incentivize suppliers to expand production. According to pharmaceutical industry expert Walter Kalmans:
[I]f you were a generic injectable manufacturer with finite capacity, would you focus your capacity on manufacturing generics for products that have just lost patent protection, reaping high profits for the next few quarters, or would you manufacture lower priced generics, drugs whose patents expired long ago? . . . ecause MMA limits price increases to 6% [semi-]annually, prices do not reach an equilibrium; even worse, because the profit potential of these drugs is so low, new entrants decide to stand on the sidelines or focus on more profitable products.25
The Department of Health and Human Services Assistant Secretary for Planning and Evaluation (ASPE) has uncovered support for Mr. Kalmans’ theory. According to an ASPE report:
Among the group of drugs that eventually experience a shortage, average prices decreased in every year leading up to a shortage. In contrast, the average prices of drugs that never experienced a shortage over this period did not change substantially either in the earlier or later period.26
The MMA’s changes only affected the reimbursement of drugs delivered in outpatient settings. Since oncology drugs tend to be administered in an outpatient setting, the Committee asked the five largest American manufacturers of generic injectable products whether they are producing a significant number of oncology drugs at a loss. According to one company, “[t]he rapid price declines and significant market shares controlled by a few customers often results in any number of manufacturers exiting the market because they have lost considerable market share and can no longer justify the manufacture of the product.” While this answer highlights the problems from the MMA, it also points to the contributing role of the GPOs in increasing market concentration. A second company responded that it is producing about three-quarters of its nearly two dozen oncology drugs at a loss, and the company believes that the MMA had the unintended effect of reducing prices to dangerously low levels:
We note at the outset that the interplay of drug pricing and shortages is complicated, and the Medicare Modernization Act made that even more the case. We do believe that the government pricing methodologies (e.g., reimbursement based on ASP instituted by MMA, and so-called “penny pricing” under the 340B program) have reduced our margins and, in a number of cases, resulted in negative cash flows when compared to average non-Medicare pricing. . . . We believe that the MMA and other government pricing policies have had unintended consequences affecting our ability to make a reasonable profit margin, not only for our oncology products but also for certain other products.
Last month, the National Bureau for Economic Research published a working paper by Ali Yurukoglu on the connection between the MMA and the drug shortage problem.27 His findings “provide evidence that the reactions of manufacturers to reducing health care expenditures likely reduced capacity and maintenance investments, and resulted in an increase in shortages.”28 Yurukoglu found that drugs more affected by the policy change (those used predominantly by older patients) were more likely to be in shortage than drugs less affected by the policy change. The Committee’s findings, along with Yurukoglu’s research, provide substantial evidence that the MMA had a large and negative unintended consequence of increasing concentration in the generic injectable drug market and reducing company incentives to make upgrades to manufacturing lines producing those generic injectable drugs. However, most of the injectable drugs on the shortage list are primarily administered in hospitals and are not substantially impacted by the pricing changes made by the MMA. This suggests that there is a more significant cause of the widespread shortages than pricing problems.
IV. FDA’s Role in Causing the Drug Shortages
Like all government regulations, FDA’s regulation of the nation’s drug supply has benefits and costs. The main benefit of FDA regulation occurs when the agency prevents harmful drugs from reaching consumers. The main cost occurs when FDA action delays or prevents beneficial drugs from reaching consumers. Many economists have assessed the net benefit of FDA regulation by quantifying Type I errors (FDA allowing a harmful drug) and Type II errors (FDA disallowing beneficial drugs). Most studies have found that the harm from Type II errors far exceeds the harm from Type I errors, meaning FDA regulation too frequently prevents or delays life-saving and life-enhancing drugs and devices from reaching Americans in need.29
Beginning in the late 1960s, drug approval time in the United States began to significantly exceed approval time in Europe. Researchers used the difference in drug approval speed to determine whether faster approval in Europe led to more unsafe drugs. Researchers compared product withdrawals in the United States with product withdrawals in Great Britain and Spain, each of which approved more drugs than the U.S. in the study period. They found no evidence that the United States had fewer recalls or that the drugs in the United States were safer.30 In another study, economists who compared the impact of FDA’s extremely slow approval for a beta-blocker in the 1970s relative to approval time in Europe found that the FDA’s delay was responsible for tens of thousands of premature deaths.31 Moreover, economist Samuel Peltzman found that many drugs are simply not developed because of stringent FDA regulations.32
Many FDA experts believe the incentives of FDA officials to be risk-averse and focus on avoiding Type I errors relative to avoiding Type II errors to be a large part of the problem.33 For example, when FDA allows a harmful drug, victims are identifiable and will likely cause shame and embarrassment for the agency. However, the victims who never gain access to drugs which are never developed are not identifiable.
Information obtained by the Committee shows that the FDA has not had a sufficient focus in ensuring access to and a continued supply of needed medicines over the last several years. Although manufacturers are reluctant to speak publicly about problems with their governing agency, the Committee found that the new political regime at FDA is largely to blame for the sudden spike of shortages that began in 2010. This conclusion is based on a months-long effort that included obtaining information from the five largest American suppliers (APP Pharmaceuticals, Bedford Laboratories, Hospira Pharmaceuticals, Sandoz Pharmaceuticals, and Teva Pharmaceuticals) of generic injectable medications and other experts. Although FDA’s detection methods for finding minute impurities have improved, it appears FDA’s enforcement and regulatory activities were unhinged from 2009 to 2011.
In June 2009, Margaret Hamburg became Commissioner of the FDA. Two months later, Commissioner Hamburg gave a speech at the Food and Drug Institute outlining her priorities and indicating that the FDA would significantly increase its enforcement activity and stringency:
When the FDA finds that a firm is significantly out of compliance, we expect a prompt response to our findings. Once the FDA provides inspection findings identifying a serious problem, the firm will generally have no more than fifteen working days in which to respond before the FDA moves ahead with a warning letter or enforcement action. This will help FDA issue warning letters on a timely basis and facilitate prompt corrective action. . . . [T]he FDA will take responsible steps to speed the issuance of warning letters. . . . The FDA is fortunate to have received significant funding increases for the current and next fiscal year that will be devoted to additional inspection and compliance activities that will support the elements of an effective enforcement strategy that I have outlined.34 [emphasis added]
As a result of the FDA’s intensified inspection and compliance efforts to “facilitate prompt corrective action,” four of America’s five largest manufacturers of generic injectable products have taken unprecedented and simultaneous remediation efforts. Remediation efforts are company efforts to resolve compliance issues raised by the FDA in a warning letter or required by a consent decree of permanent injunction.35
Since December 2009, each of the manufacturers who have shut down production lines in the past year received FDA warnings letters for their facilities that manufacture generic injectable medications. The warning letters each contain this explicit threat of enforcement action:
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice including, without limitation, seizure and injunction.36
The graph on the next page shows that the number of FDA warning letters has increased dramatically over the past two years. In the first year that Margaret Hamburg was FDA Commissioner, the number of warning letters increased 42% – from 474 letters to 673 letters. In Margaret Hamburg’s second year as FDA Commissioner, the number of warning letters increased a staggering 156% – up to 1,720 letters. While these figures include all FDA warning letters across all areas, they clearly show a dramatic change in FDA’s regulatory approach.
The simultaneous remediation effort undertaken by America’s manufacturers of generic injectable medications is problematic since virtually all injectable drugs used in the United States are manufactured in the United States.37 Prior to their remediation efforts, Hospira, Teva, Bedford, and Sandoz were producing nearly one billion units of generic injectable products per year. Facilities at these companies are currently operating at about 700 million units per year, a 30% decrease in manufacturing capacity at America’s primary production facilities for generic injectable drugs. This decrease is a massive reduction in the industries’ capacity to supply the nation with injectable medications. Pharmaceutical companies, despite running available production lines around the clock, are now forced to decide which drugs to continue producing and which to stop producing, and whether to cease production temporarily or permanently. Since generic injectable producers earn low marginal profits for older generic injectable medications, companies have an incentive to cease their production when their capacity is restricted.

...

One obvious question that FDA should answer is why nearly all of America’s major producers of generic injectable medications were essentially required to remediate facilities at the same time. It was this simultaneous remediation that reduced available capacity at these facilities by 30% relative to capacity in 2009.

...

FDA regulatory actions need to be put in proper context. Companies have strong incentives to maintain quality, even absent FDA regulations. If drug manufacturers produce drugs that are unsafe or ineffective, they risk losing business or going out of business from market competition. Moreover, the threat of tort lawsuits incentivizes manufacturers to produce safe and effective drugs.

==============

Prior to the early 1960's drug companies were not regulated and for the reasons stated in the last paragraph above, they didn't put out bad drugs. Since then the cost of getting a drug approved and to market has gon from a couple hundred thousand dollars to billions! time from discovery to market has gone from an average of 2 years to over a decade.

Want cheap and safe drugs and an end to drug shortages? The answer is simple:

[B]ABOLISH THE FDA!!!!

-t

tod evans
11-17-2012, 08:22 PM
If I'm ever diagnosed with a terminal disease this will be my drug of choice.

Fuck the FDA and their regs, I'm a pussy when it comes to pain and I know what works.


I will never forget when I heard someone (do recall who... methinks some medical official but do not quote me on it) justify the denial of heroin and similar drugs to terminal cancer patients who were in blind agony on the grounds that they "might become addicted".

Clearly I am just a man because no matter how strongly I believe in and advocate for the respect of human rights, I cannot always escape the nearly overwhelming urge to beat a specific person savagely with a bat because their shrieking, teeth gnashing stupidity should be met with nothing less.

osan
11-17-2012, 08:23 PM
Farmers in Iowa could solve this pretty quickly, if our government were not psycopathically authoritarian.

Shoot, I can grow acres of opium poppies any time. In fact, I often do. It is somewhat surprising that this has not yet been banned along with pot and other such botanicals. Nothing prettier than an acre or two of red and lavender poppies. Hmmm... now that you have me thinking about it, methinks this coming spring I should spread 20 or 30 pounds of seed in the front field.

tangent4ronpaul
11-17-2012, 08:25 PM
Absolute total and utter bullshit!

There's a reason every medic in the US carries ONLY morphine onto the battlefield, it fucking works!

And yes I have the years and 1st hand experience to make that statement..

Actually versed lollipops are commonly carried today.

-t

tod evans
11-17-2012, 08:32 PM
Actually versed lollipops are commonly carried today.

-t

It's been 30 years..:o

tangent4ronpaul
11-17-2012, 08:42 PM
Shoot, I can grow acres of opium poppies any time. In fact, I often do. It is somewhat surprising that this has not yet been banned along with pot and other such botanicals. Nothing prettier than an acre or two of red and lavender poppies. Hmmm... now that you have me thinking about it, methinks this coming spring I should spread 20 or 30 pounds of seed in the front field.

http://www.aussurvivalist.com/downloads/AM%20Final%202.pdf
(From page 75 of Survival and Austere Medicine)

9. Poppy (Papavar somniferum):
Be aware of the local legal status of poppies, and be aware that illegal possession of
opiates has harsh penalties. Also note that there are a number of different poppies
and most bought from the plant shop are not Papavar somniferum)
Harvest resin when the seed pod is fully formed, green, and juicy looking; harvest
seed when the seed pod has dried, brown, and hard. Tincture, water infusion.
When the fully formed seed pod is fat, juicy looking, and still green use a small sharp
knife tip to make 3-4 shallow slits 2/3rds the way down the seed pod from the top to
bottom direction, space the cuts evenly around the pod. The resin will slowly ooze out
and begin to air harden, daily scrape off the semi hardened resin from the cuts and
(wearing surgical gloves) shape the resin into a ball shape. Store in a glass container,
cool and dark. Each day form the newly collected resin onto the ball. When the resin
no longer oozes make 3-4 new cuts, spaced between the old ones evenly, and repeat
the process. Three series of cuts per pod is sufficient. When the seed pod fully dries,
and turns brown, and hard, and you can hear the seeds rattle when you gently shake
the pod, pick the whole pod, and break open over wax paper or paper towel to harvest
the seeds. Let a few pods remain on the stems and the plant will self-seed for the next
year.
You can tincture the seeds or resin and also use the seeds for a severe pain relieving
tea to use if the patient is conscious. A dropperful of the tincture might be used by
inserting under the tongue of an unconscious patient.
Poppy seeds are usually planted outside when the ground is warm in the spring, partial
to full sun, moderate water. Will self-seed if pods left intact on the stem.

http://www.ktbotanicals.com/papaver-somniferum-opium-poppy-seeds-p-98.html
http://www.bouncingbearbotanicals.com/opium-poppy-p-152.html
http://www.onestoppoppyshoppe.com/servlet/the-Annual-Poppy-Seeds-cln-Papaver-somniferum/Categories
http://www.amazon.com/Somniferum-Papaver-somniferum-Seed-Needs/dp/B003TJKMKW
http://www.ethnobotanicals.com/opium-poppy-seeds.html

It's also worth noting that poppy seed pods can be found for sale in some craft supply stores for flower arranging. These can be used to make poppy tea.

They sure are perdy flowers... My mom used to grow some at the house I grew up in. Might plant a few here next spring...

-t

UWDude
11-18-2012, 01:03 AM
They've been trying, but our government is doing what it does...

Which is protecting the poppy fields.

http://www.youtube.com/watch?v=aj-b3pB6M7s

Geraldo reports it here on Fox news, and Lt. Colonel Brian Christmas, commanding officer of third battalion, 6th Marines, justifies the protecting of the fields. Watch and be amazed.

tod evans
11-18-2012, 06:33 AM
Seen it...Now pay attention to what happens once the opium is harvested....watch where both the money and the dope go...


Which is protecting the poppy fields.

http://www.youtube.com/watch?v=aj-b3pB6M7s

Geraldo reports it here on Fox news, and Lt. Colonel Brian Christmas, commanding officer of third battalion, 6th Marines, justifies the protecting of the fields. Watch and be amazed.

UWDude
11-18-2012, 07:23 AM
I know where they go. They go to the pharmaceutical companies that use them for a base of a whole host of drugs, and they go to the streets of every nation in the world, distributed by the same cartel that delivered crack to the inner cities of America.

tod evans
11-18-2012, 07:28 AM
I know where they go. They go to the pharmaceutical companies that use them for a base of a whole host of drugs, and they go to the streets of every nation in the world, distributed by the same cartel that delivered crack to the inner cities of America.

Finish the thought.......

Under whose supervision does this refinement and marketing take place?

Where do the profits go?

Stopping at the politically correct "cartels" is a cop-out!

Or maybe that was intentional....

UWDude
11-18-2012, 07:14 PM
Finish the thought.......

Under whose supervision does this refinement and marketing take place?

Where do the profits go?

Stopping at the politically correct "cartels" is a cop-out!

Or maybe that was intentional....

The "cartel" I was speaking of was the CIA. I don;t know what you are harping about.

Oh, and I know a marine that loaded the heroin onto hueys in Vietnam. Shit was real, always has been real.

Anti Federalist
11-18-2012, 07:35 PM
The "cartel" I was speaking of was the CIA. I don;t know what you are harping about.

Oh, and I know a marine that loaded the heroin onto hueys in Vietnam. Shit was real, always has been real.

In the 60s it was heroin and opium from Laos and Cambodia.

In the 80s it was coke and guns through cut outs in Central America and government actors working in Bill Clinton's Arkansas.

Read "Compromised" by Terry Reid.

Now it's opium from Afghanistan and murder of our own high profile soldiers who were going to blow the whistle on the whole stinking, suppurating mess.

tod evans
11-18-2012, 08:16 PM
The "cartel" I was speaking of was the CIA.

Clarification makes all the difference...;)

presence
11-18-2012, 08:30 PM
A nationwide drug shortage has left American hospital patients untreated and in pain. Manufacturing problems have left emergency care providers without some of the most crucial medicines, putting lives at risk.


More than 100 drugs were put on the shortage list this year, prompting Congressional hearings and leading to an executive order by President Barack Obama, which forces drug companies to publicize their shortages.


Health care workers have had no other option than to ration some medicines, giving it only to patients that need it most. Paul Davis, the chief of a rural ambulance squad in Ohio, told the New York Times that he was unable to give morphine to a woman with a broken leg because he was saving his last pills for patients he thought needed it more.

Elsewhere, desperate health care workers are treating patients with expired drugs and less effective medicine. Those with cancer have been hit particularly hard. About 80 percent of the drugs in short supply are generic medicines for injection, including the chemotherapy treatment drug Doxil, WFTV reports. Sodium bicarbonate injections, which are used to stabilize critically ill patients suffering from sepsis, heart attacks or other cardiac problems, are also in short supply.


“When you can’t treat basic things – cardiac arrest, pain management, seizures – you’re in trouble. When you only have five tools in your toolbox and three of them are gone, what do you do?” Dr. Carol Cunningham, state medical director for the Ohio Department of Public Safety’s emergency services division, told the Times.

While this year’s shortage has left many without the care they needed, it is not as critical as the 2011 drug shortage, which left more than 250 drugs in short supply and threatened the lives of cancer patients. Since 2005, drug shortages have increased almost 300 percent. To combat the problem, the FDA has relaxed its restrictions on importing drugs and made it easier for manufacturers to get approval to make certain medicines.


But this, too, has brought further problems to health care providers. With looser regulations, manufacturers have been able to get poor-quality medicines onto the market, including a chemotherapy drug that was found to contain glass particles.

And the shortages are predicted to get worse.

http://rt.com/usa/news/drug-shortage-us-morphine-014/

Origanalist
11-18-2012, 08:34 PM
The "cartel" I was speaking of was the CIA. I don;t know what you are harping about.

Oh, and I know a marine that loaded the heroin onto hueys in Vietnam. Shit was real, always has been real.

Get off the 666 posts dude. :eek:

As a side note, remember when they caught some of the Asian community members growing poppies by the freeway in Seattle?

presence
11-18-2012, 08:39 PM
The "cartel" I was speaking of was the CIA. I don;t know what you are harping about.

Oh, and I know a marine that loaded the heroin onto hueys in Vietnam. Shit was real, always has been real.

Funny, I was on youtube watching footage of all that yesterday. Maybe "secrets of the cia" or something like that? no link, sorry.

tangent4ronpaul
11-18-2012, 09:25 PM
As a side note, remember when they caught some of the Asian community members growing poppies by the freeway in Seattle?

No - what's the story?

-t

Origanalist
11-18-2012, 09:38 PM
No - what's the story?

-t

I don't have the complete story, that's why I was asking. My mother has told this to me a few times now. I didn't hear about it, but for some strange reason it really tickled her funny bone. I guess some Asians (I only say that because I'm not sure which country they were from) had a pretty sizable patch of opium poppies growing alongside the freeway downtown and got away with it for quite a while until somebody caught on.

idiom
11-18-2012, 10:55 PM
Why gosh!, who woulda thunk that the gubmint would be responsible for the shortages...

FDA’s Contribution to the Drug Shortage Crisis

The Committee has learned that FDA regulatory activity has effectively shut down 30% of the total manufacturing capacity at four of America’s largest producers of generic injectable medications: Bedford Laboratories, Hospira Pharmaceuticals, Sandoz Pharmaceuticals, and Teva Pharmaceuticals.

Stupid question.

How many plants manufacturing pharmaceuticals that have been shut down by the FDA in the past two years were for non-generic pharmaceuticals?

idiom
11-18-2012, 11:01 PM
Now it's opium from Afghanistan and murder of our own high profile soldiers who were going to blow the whistle on the whole stinking, suppurating mess.

+1 for 'suppurating'

tangent4ronpaul
11-18-2012, 11:43 PM
Stupid question.

How many plants manufacturing pharmaceuticals that have been shut down by the FDA in the past two years were for non-generic pharmaceuticals?

Please elaborate? I don't know if I should slam you or praise you....

-t

idiom
11-19-2012, 12:14 AM
I don't actually know.

My cynical guess is that is probably between none and zero. I this was the case it would be pretty damning circumstantial evidence of industry collusion to push non-generic drugs.

Not that we need any evidence of that.