A Lipitor molecule

 

 

GoogleNews.com, by Simeon Bennett, April 7 (Bloomberg) — Pfizer Inc., the maker of Viagra and the world’s biggest-selling drug Lipitor, said it expects to have more products with sales in excess of $1 billion as it develops treatments for Alzheimer’s disease, cancer and pain.

“We’re in the golden age of drug discovery,” Martin Mackay, president of pharmaceutical research at the New York- based company, said today in an interview with Bloomberg Television in Singapore. “We have a very replete pipeline in key areas such as cancer, Alzheimer’s disease, pain and inflammation” and infectious diseases.

Pfizer needs new products as it faces the November 2011 patent expiration of Lipitor, which accounted for $11.4 billion in sales last year, more than one-fifth of revenue. The company, the world’s biggest drugmaker, is also betting on treatments it got by buying rival Wyeth for $68 billion in October.

Nine of the company’s drugs sold at least $1 billion last year, according to data compiled by Bloomberg, qualifying them as “blockbusters.”

Mackay cited new products including tasocitinib for rheumatoid arthritis as among those that will replace lost revenue from cholesterol-controlling Lipitor. He also said the company will increase the variety of products it sells rather than try to replace one blockbuster with another.

‘Single-Digit Growth’

“The strategy at Pfizer is to be a very solid growing company, albeit with single-digit growth, and be a diversified company which not only has pharmaceuticals and new pharmaceuticals coming out of R&D, but nutritionals, consumer products, animal-health products, and the like,” Mackay said. “To contemplate double-digit growth is going to be difficult over the next period,” he said, referring to sales growth.

As of the end of last year, Pfizer had 26 drugs in phase- three trials, a final stage of testing required for U.S. approval, compared with eight at the end of 2007, Mackay said. That doesn’t include the treatments it got from Wyeth, he said at a briefing at the company’s research unit in Singapore.

Following the acquisition, Pfizer cut its research portfolio to 500 projects from 600, as it focuses on accelerating the development of drugs with a “big, early” effect in patient studies while weeding out the losers earlier in the process, Mackay said.

“Flatliners are flatliners, and they kill us unless you find them really early,” Mackay said. “In the next few years I think you’ll see less attrition, more survival of our compounds, and taking that attrition earlier.”

Clinical Trials

The company runs about 600 trials worldwide each year, including about 90 in phase one, the first stage of human testing, Mackay said. Of those, 23 were done last year in Singapore, a figure Pfizer wants to increase by about 10 percent this year as it tests more treatments for Asian populations.

Pfizer today said it will collaborate with closely held MicuRx Pharmaceuticals Inc., based in Union City, California, and China-based Cumencor Pharmaceuticals Inc. to develop antibiotics for drug-resistant tuberculosis in China. Pfizer will pay an undisclosed upfront fee, fund the discovery and development of the antibiotics and make payments linked to marketing the products, it said in a statement.

China has more than 25 percent of the world’s multi-drug resistant tuberculosis, Pfizer said, citing the World Health Organization.

To contact the reporter on this story: Simeon Bennett in Singapore at sbennett9@bloomberg.net

Last Updated: April 7, 2010

Philip R. Davis is a founder of Phil’s Stock World (www.philstockworld.com), a stock and options trading site that teaches the art of options trading to newcomers and devises advanced strategies for expert traders. Mr. Davis is a serial entrepreneur, who founded software company Accu-Title.

This is a brief article of where the pharmaceutical industry has been, and where it could be headed in the near future.  In contrast to past articles where I focused on the pipelines of GSK, LLY, MRK, BMY and ‘biotechs’ GENZ, GILD, and others, this is a summary of the industry.  The overall market continues its grind up and I am gun-shy of its continued direction, but with the passage of the health care bill, biotechs that serve niche markets will be well positioned to see a rise both in stock price and potential M&A activity.  In addition, as noted on Friday, March 19th on the laggers/leaders of the past month or so, Telecom and Healthcare were at the bottom of the pile.  For the review of Big Pharma and some biotech picks at the end, generic companies are excluded from most data (Merck KGaA, Mylan, Teva and Watson).

From 2002 to 2009, the top pharmaceutical companies by sales had growth rates greater than 12% (compounded annually).  Unfortunately, this growth is not sustainable and should move towards flat to nominal growth by 2014.  The growth decline will challenge these companies to seek more profitable routes, including licensing and acquisitions.  Picking the right companies based upon the science is at the forefront of good investing.  Not they will all succeed because the science is sound, but understanding the molecule, target, and the disease helps guide smart decisions.  Good management helps as well!

Let’s start with a summary of potential acquirers.  Table 1 is a list of the 15 largest pharmaceutical and biotech companies ranked by healthcare revenue.  Some companies (e.g., Bayer and Johnson) have additional revenue which is not included the sales data.  

Table 1. Top 13 Pharma Companies in Sales (2009)

Rank Company Sales ($M) Based/Headquartered in
1 Pfizer 50,001 US
2 Hoffmann–La Roche 46,300* Switzerland
3 Merck & Co. 45,930** US
4 Novartis 45,080 Switzerland
5 GlaxoSmithKline 42,600 UK
6 Sanofi-Aventis 40,100 France
7 AstraZeneca 32,800 UK/Sweden
8 Johnson & Johnson 24,600 US
9 Eli Lilly and Company 21,840 US
10 Abbott 16,500 US
11 Amgen 15,794 US
12 Wyeth 15,682^ US
13 Bayer 15,988 Germany
14 Takeda 15,697 Japan
15 Teva 13,900 Israel
       
  Total 442,000  

 

* includes Genentech; ** est. using Schering Plough 2008 Revenue; ^2008

The Bad:  In 2008, the Pharma industry had $773B in sales (IMS Health), and if the growth rate was the projected 2%, sales would have been about $788B in 2009.  Thus, the top 13 companies listed above comprised 56% of 2009 sales ($442B).  Unfortunately 2010-2012 is going to be painful for several companies’ bottom lines, as many blockbuster drugs (those with over $1B in sales) will come off patent, including Lipitor (2011), Plavix (2011) and Singulair (2012). A partial list of expirations are noted in Table 3 below. The pharmaceutical industry is expected to lose ~$50B in sales through 2012.

Table 3. Patent Expirations and Sales Data

Company Name Indication Sales as of 2009 (in Billions) Date off Patent
Pfizer/Eisai Aricept Alzheimer’s 1 2010
Merck Cozaar Hypertension 3.6 2010
Pfizer Lipitor Cholesterol 12.5 2011
JnJ Levaquin Antibiotic 1.5 2011
Sanofi/BMS Plavix Anticoagulant 9.3 2011
AZ Seroquel Antipsychotic 4.9 2011
Lilly Zyprexa Antipsychotic 4.9 2011
Merck Singulair Asthma 4.7 2012
Forest Labs/Lundbeck Lexapro Antidepressant 2.3 2012
AZ Symbicort Asthma 2.3 2012
Novartis Diovan Hypertension 2.9 2012
         
Total     49.9  

 

Data from 2009 Annual Reports

In recent years, the pharmaceutical industry revenue growth has slowed for several reasons, including:

  • tighter reimbursements from managed care markets – although in the US many have done the Pharma companies well with the prescription drug act, 
  • weakened global economiesself explanatory
  • the loss of patent protection on blockbuster drugs (e.g., Zocor), and 
  • relatively sluggish new product flow – big Pharma is not as efficient as they once were, and biotech or small pharma are much more (less bureaucracy and/or defending pet projects).  Lilly is conducting the grand experiment of sorts by outsourcing some decision making!

Pipeline Scores: Analyzing Late-Stage Drug Candidates 

As of September 2009, Morningstar’s pipeline scores combine the number of drugs under development of each company and weigh drug candidates by market potential, launch timing, and probability of approval.  GlaxoSmithKline leads the group as the company holds a very high number of near-term product launches, including human papillomavirus vaccine Cervarix and several new cancer drugs (I said it in August 2009).  On the flip side, Abbott’s (ABT) pipeline is relatively weak (and I noted this in a past write-up as well), and it is anticipated the firm will attempt to enhance it in the near future through targeted acquisitions and licensing.  Further I noted many times in my write-ups that NVS and MRK have great pipelines.  I disagree with Morningstar’s pipeline score with Pfizer, as I believe they have overpaid for Wyeth and not focused enough on the science behind the pipeline (internal or otherwise).  

Why is Pfizer in for stormy weather? 

For now, Pfizer’s drug portfolio is unmatched in terms of breadth and depth in the global drug market due to its acquisitions of with Warner-Lambert (2000) (Lipitor), with Pharmacia (2003) (Celebrex), and now Wyeth (2009). (See a trend – BUY the pipeline). 

Principal cardiovascular drugs include Lipitor, the world’s largest-selling cholesterol-lowering agent as well as the biggest drug in any therapeutic category in 2009 (sales of $11.4 billion), antihypertensives such as off-patent Norvasc ($2.0 billion), and Caduet ($548 million), a combination of Lipitor and Norvasc.  Key central nervous system medicines include Lyrica, a treatment for nerve pain and epileptic seizures ($2.8 billion); and Geodon, an antipsychotic ($1.0 billion).  The infectious disease area consist of Zyvox ($1.1 billion) and Vfend ($743 million), an anti-fungal.  Other key drugs sold include Celebrex COX-2 inhibitor for arthritis and pain (sales of $2.4 billion); Viagra for male erectile dysfunction ($1.9 billion); Xalatan/Xalcom, for glaucoma ($1.7 billion); Detrol and LA/Detrol, treatments for incontinence ($1.2 billion); Sutent ($964 million) for kidney and other cancers; Genotropin ($887 million), a human growth hormone; and Chantix ($700 million) for smoking cessation.  Non-US sales accounted for 57% of total revenues in 2009.  The animal health division ($2.8 billion) offers one of the largest-selling and broadest product lines in its field.  Other products include feed additives, vaccines, antibiotics, antihelmintics, and other veterinary products.  

After Wyeth is incorporated for a full year, projected revenues should climb to $68B in 2010, from 2009’s adjusted $50B.  Growth should be in several areas including Lyrica, Zyvox, Sutent, Celebrex and Geodon.  On the Wyeth growth drivers, Prevnar vaccines and Enbrel should increase.  Enbrel, though, is aTNF inhibitor and this competes against Remicade from JNJ and Humira from Abbott.  I believe there is a price war breaking out, so the revenues should grow, but profits may be sacrificed.  

So what gives with Pfizer?  First, every compound that makes it into clinic (Phase I through Phase III) trials is destined to fail.  Once in clinic, roughly 1 in 10 compounds makes it to market (I think the stats are getting worse, but I do not have the most recent).  To discover 1 compound, Pharma goes through 3,000-20,000 compounds (if it is a small molecule like Lipitor).  Monoclonal antibodies and other biologics are much less, but the production and testing is rigorous, long, and they a very different attrition rate that I will not cover here.  Thus, my problem with the PFE pipeline is as follows:  PFE had 100 compounds (some are monoclonal antibodies) in the pipe in 2009 and currently, with the WYE addition, has 133 in 2010.  Thus, 13 should make it to market!  While this looks great because of the merger, they acquired WYE, for $68B, and PFE only has 33 more drugs in the clinic?  That is $2B/compound!  Smaller companies can develop a compound for clinic for ~$20M.  If a smaller company can do that 100 times, then by the laws of averages, they should have 10 compounds one the market for $2B.  Further, with the failure of drugs from Medivation, Neurocrine, Exubera (inhaled insulin) and other big named programs in the past few years, it makes me wonder what the heck they are doing when they sign these big deals.  I am oversimplifying the costs to market, but I am trying to make a point on efficiencies and innovations of smaller companies.  Something PFE lacks, but NVS, MRK, GSK, and others use a balanced approach to drug discovery.  It is all about the science. (Oh, and they have 40B in debt.  Those drugs better pay off.)

http://media.pfizer.com/files/research/pipeline/2010_0127/pipeline_2010_0127.pdf

The rest of Pharma is awash in cash, and M&A is a powerful tool for improving operating profits (oh, and laying-off lots of people).  You can bet that Big Pharma is GOING to use M&A and layoffs as their strategies (layoffs have already started with the mergers and AstraZeneca).  With recovery from the global economic downturn, and the passage of the health care act of 2010, M&A deals will be increasing.  As the mega-mergers made a comeback in 2009 (each worth over $40 billion: Pfizer-Wyeth, Merck-Schering-Plough and Roche-Genentech), smaller deals are right around the corner.  M&A, though, cannot totally offset falling sales from the impending 2012 patent cliff, but the M&As can improve the profitability associated with greater sales (co-branding products like Vytorin, Caduet, etc), it can create a cost-saving opportunity (layoffs).  In the end, some combination of the two will ensure Pharma’s continued relationship with M&A, and I believe it will even be greater importance in the coming years.

So, which companies might be acquired?  Using Table 4, I see several companies that could be targets, including the biggest fish Amgen and BMY, smaller fish Genzyme, Biogen Idec (Ican wants to sell them to someone), and BioMarin.  Amylin (Ichan would like to sell them to someone as well) is in bed with Lilly, so they could be a target for the right price, but they remain in a tough spot due to the pricing pressures and clinical outcome studies against the DPP-IV small molecules on the market (Januvia) or ones rolling through the pipelines (e.g., Takeda).  Orphan indications (this includes cancer) and Immunological disorders are going to be the real drivers of future growth, so companies that focus on these areas should do fairly well given sound science rationale. 

Table 4. Top 10 Biotech Companies in Sales (2009; *2008)

Rank Company Sales ($M) Market Cap ($M) Based/Headquartered in  
1 Amgen 14640 59,000 US  
3 NovoNordisk 9290 48,000 Denmark  
5 Gilead 7010 43,000 US  
4 Genzyme 4520 15,700 US  
6 Biogen Idec 4380 16,300 US  
           
Others of Interest        
  BioMarin 325 1,700 US  
  Amylin 725 3,700 US  
           
Small Cap          
  Amicus 65 75 US  
  Ariad 8 403 US  
  Curis 8 241 US  
  Spectrum 37 240 US  
  Savient 3 1000 US  

 

JnJ is always on the lookout for more as they bought Cougar last year, and BMY and Amgen are a potential targets for them (JnJ really wants to expand their Pharma, and they are good at buying, but their research unit is less than stellar).  Others worth considering are Spectrum, Ariad, Curis, Vertex, Savient, and even Shire.  Stay tuned for further readings on the companies noted above for potential entries over the coming weeks in member chat. 

Disclosure: none

Stocks: BMY, GENZ, JNJ, MRK, PFE, SPPI, SVNT

Instablogs are blogs which are instantly set up and networked within the Seeking Alpha community. Instablog posts are not selected, edited or screened by Seeking Alpha editors, in contrast to contributors’ articles.

GoogleNews.com, StarTribune.com, April 7, 2010, by Gary Fine  –   “A new technology developed at Hadassah University Medical Center has made it possible to produce large amounts of human embryonic stem cells (hESCs) for industry and research by growing them in suspension. Until now, hESCs – which have the potential of ripening into any other type of body cells for repair of tissues and organs – have been created in small numbers.”

In the past stem cells have been grown on beds in one layer. The Hadassah researchers were able to cultivate the stem cells for the first time in large vats with precise, computerized monitoring of growth conditions.

Called a “breakthrough” in hESC technology—The article, titled “Derivation, propagation and controlled differentiation of human embryonic stem cells in suspension,” was written by Dr. Debora Steiner as part of her post-doctoral work under the direction of Prof. Benjamin Reubinoff, both of Hadassah’s Human Embryonic Stem Cell Research Center, with participation by other Hadassah colleagues. HESC research has been stymied by the fact that it has, until now, been difficult to make large amounts of them.”- Judy Seilgel-Itzkovitch.

 A German study “conducted by the Central Library of the ResearchCenter Julich, then confirming Israel’s prominence in stem cell research showed that Israel “is the leading publisher of stem cell research per capita in the world. According to the report, which covers the years 2000-2004, Israel publishes 113 articles per every 1 million citizens, a ratio that exceeds any other country in the world. Israel is followed in rank by Sweden, Switzerland, the Netherlands and Austria. The US places at sixth, though it comes in first when judged by sheer volume alone at 13,663 articles compared to Israel’s 690.”- A Marguiles 2006

“Israel is among a small group of countries that have developed their own stem-cell regulations that permit most types of work in the field. Israel’s carefully regulated but open atmosphere for research has helped catapult it into the front ranks of a field that many consider the next frontier of science. “What Israel has done in the laboratory and in their oversight mechanisms is a model for other nations to emulate,” said Georgetown University’s LeRoy Walters, an expert in the global dimensions of stem-cell research.

“Israel’s move toward the front rank began at the dawn of the embryonic stem-cell age, in 1998. In that year an Israeli scientist from the Technion – Israel Institute of Technology, Joseph Itskovitz, was on the University of Wisconsin team that first isolated and grew stem cells from a human embryo. The next scientist to achieve that feat was Benjamin Reubinoff, a Hadassah researcher.”-N. Popper 2004, Forward

Recall — Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Media Contact:
Libba Letton, Whole Foods Market
512-542-3031

FOR IMMEDIATE RELEASE – April 7, 2010 – Whole Foods Market announced the recall of its Whole Catch Yellow fin Tuna Steaks (frozen) with a best by date of Dec 5th, 2010 because of possible elevated levels of histamine that may result in symptoms that generally appear within minutes to an hour after eating the affected fish. No other Whole Foods Market, Whole Catch, 365 or 365 Organic products are affected.

The product, sold in twelve ounce bags with Best by Date: exp 05 DEC 2010 with Lot Code: 4853309157A and displays the following UPC code:

  • 0-99482-42078-9 Whole Catch Yellow fin Tuna Steaks (Frozen) 12 oz.

High levels of histamine can produce an allergic reaction called scombroid poisoning when the fish is consumed. The following are the most common symptoms of scombroid poisoning: tingling or burning sensation in the mouth, facial swelling, rash, hives and itchy skin, nausea, vomiting or diarrhea. However, each individual may experience symptoms differently.

There have been two reported incidents by consumers. Whole Foods Market feels that while these were isolated incidents, every precautionary measure should be taken when it comes to consumer health and safety. This recall does not impact any other fish or seafood sold by Whole Foods Market.

If consumers have this product with the indicated UPC code and Best By date, they may return it to the store for a full refund. Consumers with questions may contact the company by calling 512-542-0656 begin_of_the_skype_highlighting              512-542-0656      end_of_the_skype_highlighting.

Whole Foods Market has removed the affected lot code from all store shelves. Product was distributed to 28 states plus the District of Columbia including Texas, Oklahoma, Louisiana, Illinois, Indiana, Kansas, Ohio, Wisconsin, Minnesota, Missouri, Michigan, Maryland, Virginia, Pennsylvania, Florida, Alabama, Georgia, Kentucky, South Carolina, Tennessee, North Carolina, Connecticut, Nebraska, New Jersey, New York, Maryland, Rhode Island, Maine and Washington, D.C.

#

read another FDA NEWS RELEASE

For Immediate Release: Apr. 7, 2010
Media Inquiries: Karen Riley, 301-796-4674

karen.riley@fda.hhs.gov
Consumer Inquiries
: 888-INFO-FDA

The U.S. Food and Drug Administration today approved a new formulation of the controlled-release drug OxyContin that has been designed to help discourage misuse and abuse of the medication.

OxyContin is made to slowly release the potent opioid oxycodone to treat patients who require a continuous, around-the-clock opioid analgesic for management of their moderate to severe pain for an extended period of time. Because of its controlled-release properties, each OxyContin tablet contains a large quantity of oxycodone, which allows patients to take their drug less often. However, people intent on abusing the previous formulation have been able to release high levels of oxycodone all at once, which can result in a fatal overdose and contributes to high rates of OxyContin abuse.

The reformulated OxyContin is intended to prevent the opioid medication from being cut, broken, chewed, crushed or dissolved to release more medication. The new formulation may be an improvement that may result in less risk of overdose due to tampering, and will likely result in less abuse by snorting or injection; but it still can be abused or misused by simply ingesting larger doses than are recommended.

“Although this new formulation of OxyContin may provide only an incremental advantage over the current version of the drug, it is still a step in the right direction,” said Bob Rappaport, M.D., director of the Division of Anesthesia and Analgesia Products in the FDA’s Center for Drug Evaluation and Research.

“As with all opioids, safety is an important consideration,” he said. “Prescribers and patients need to know that its tamper-resistant properties are limited and need to carefully weigh the benefits and risks of using this medication to treat pain.”

According to the U.S. Substance Abuse and Mental Health Services Administration’s National Survey on Drug Use and Health, approximately half a million people used OxyContin non-medically for the first time in 2008.

The manufacturer of OxyContin, Purdue Pharma L.P., will be required to conduct a postmarket study to collect data on the extent to which the new formulation reduces abuse and misuse of this opioid. The FDA is also requiring a REMS (Risk Evaluation and Mitigation Strategy) that will include the issuance of a Medication Guide to patients and a requirement for prescriber education regarding the appropriate use of opioid analgesics in the treatment of pain.

Purdue Pharma is based in Stamford, Conn.

Read more about OxyContin

OxyContin – FDA Questions and Answers

(4/5/2010)

The U.S. Food and Drug Administration has approved a new formulation of the controlled-release drug OxyContin. This new formulation is designed to decrease the likelihood that this medication will be misused or abused, and result in overdose.The new formulation adds in new tamper-resistant features aimed at preserving the controlled release of the active ingredient, oxycodone.

The following question and answers provide some additional background information on OxyContin, the misuse and abuse of this drug, and the significance of this new technology.

What is OxyContin?

OxyContin is a prescription narcotic pain reliever that was approved by FDA in 1995. It is manufactured by Purdue Pharma LP, and its active ingredient is oxycodone, a derivative of opium.

How is OxyContin used to treat pain?

OxyContin is made to slowly release the potent opioid oxycodone to treat patients who require around-the-clock medical management with an opioid analgesic for their moderate to severe pain. Because of its controlled-release properties, each OxyContin tablet contains a large quantity of oxycodone, which allows patients to take their drug less often—a distinct benefit for patients who are in chronic pain.

Why is OxyContin abused?

The primary reason OxyContin is abused is that this drug, like all opioid narcotics, can produce euphoria (a sense of well-being). Euphoria is the primary reason why people use opioids non-medicinally. Chronic non-medicinal use of euphoric-producing drugs can lead to addiction and dependence.

The wide availability of OxyContin, is secondary reason why this drug is popular to use non-medicinally. Although an individual would need a prescription to legally purchase and use OxyContin medicinally, this drug can be easily obtained through illicit channels. The high volume of OxyContin supply available to the public, and the discrepancy between the fair and black market value of the medicine, contributes to diversion, illicit sale, and abuse of OxyContin.

The rates of OxyContin misuse and abuse remain high—in 2008, the number of new nonmedical users of OxyContin aged 12 or older was approximately half a million.1

What does the new formulation of OxyContin accomplish? Does it decrease the likelihood that this drug will be misused and abused?

Over time, individuals have learned effective ways to tamper with OxyContin’s controlled-release technology. Tampering with the tablet, via cutting, chewing, breaking, or dissolving, can be very dangerous because it releases high levels of oxycodone all at once.

There have been reports of inadvertent overdose with OxyContin after health care practitioners crushed the drug in order to administer it to patients who could not swallow the tablet.

Tampering with tablets is also popular among individuals seeking OxyContin’s euphoric properties. By crushing and snorting, or dissolving and injecting, individuals received a much higher and immediate dose of oxycodone than they would if they swallowed the tablet whole.

The reformulated version of OxyContin is intended to prevent immediate access to the full dose of oxycodone via cutting, chewing, or breaking the tablet. Attempts to dissolve the tablets in liquid result in a gummy substance that cannot be drawn up into a syringe or injected. The new formulation of OxyContin reduces the likelihood that this drug will be misused and abused, although it can not completely eliminate this possibility.

The new formulation can still be abused or misused and result in overdose simply by ingesting or administering it in higher than recommended doses. Health care professionals need to remind their patients of the risks associated with using OxyContin not-as-directed.

How will FDA know if the new version of OxyContin is more resistant to drug misuse and abuse?

FDA is requiring Purdue Pharma LP to conduct a post-marketing study to determine the impact of the new formulation on the use and misuse of OxyContin. Additionally, FDA is requiring the manufacturers to follow a Risk Evaluation and Mitigation Strategy (REMS) for this product, which will include the issuance of a Medication Guide to all patients who will use this product and a requirement for prescriber education on the appropriate use of opioid analgesics in the treatment of pain.

References

1. Substance Abuse and Mental Health Services Administration. (2009). Results from the 2008 National Survey on Drug Use and Health: National Findings (Office of Applied Studies, NSDUH Series H-36, HHS Publication No. SMA 09-4434) Rockville, MD.

FDA Guide to Safe Use of Pain Medicine

 

If you’ve ever been treated for severe pain from surgery, an injury, or an illness, you know just how vital pain relief medications can be.

Pain relief treatments come in many forms and potencies, are available by prescription or over-the-counter (OTC), and treat all sorts of physical pain—including that brought on by chronic conditions, sudden trauma, and cancer.

Pain relief medicines (also known as “analgesics” and “painkillers”) are regulated by the Food and Drug Administration (FDA). Some analgesics, including opioid analgesics, act on the body’s peripheral and central nervous systems to block or decrease sensitivity to pain. Others act by inhibiting the formation of certain chemicals in the body.

Among the factors health care professionals consider in recommending or prescribing them are the cause and severity of the pain.

TYPES OF PAIN RELIEVERS

OTC Medications

These relieve the minor aches and pains associated with conditions such as headaches, fever, colds, flu, arthritis, toothaches, and menstrual cramps.

There are basically two types of OTC pain relievers: acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs).

Acetaminophen is an active ingredient found in more than 600 OTC and prescription medicines, including pain relievers, cough suppressants, and cold medications.

NSAIDs are common medications used to relieve fever and minor aches and pains. They include aspirin, naproxen, and ibuprofen, as well as many medicines taken for colds, sinus pressure, and allergies. They act by inhibiting an enzyme that helps make a specific chemical.

Prescription Medications

Typical prescription pain relief medicines include opioids and non-opioid medications.

Derived from opium, opioid drugs are very powerful products. They act by attaching to a specific “receptor” in the brain, spinal cord, and gastrointestinal tract. Opioids can change the way a person experiences pain.

Types of prescription opioid medications include

  • morphine, which is often used before and after surgical procedures to alleviate severe pain
  • oxycodone, which is also often prescribed for moderate to severe pain
  • codeine, which comes in combination with acetaminophen or other non-opioid pain relief medications and is often prescribed for mild to moderate pain
  • hydrocodone, which comes in combination with acetaminophen or other non-opioid pain relief medications and is prescribed for moderate to moderately severe pain

FDA has recently notified makers of certain opioid drugs that these products will need to have a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits continue to outweigh the risks.

Affected opioid drugs, which include brand name and generic products, are formulated with the active ingredients fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxymorphone.

FDA has authority to require a REMS under the Food and Drug Administration Amendments Act of 2007.

Types of non-opioid prescription medications include ibuprofen and diclofenac, which treat mild to moderate pain.

USE AS DIRECTED

Pain medications are safe and effective when used as directed. However, misuse of these products can be extremely harmful and even deadly.

Consumers who take pain relief medications must follow their health care professional’s instructions carefully. If a measuring tool is provided with your medicine, use it as directed.

Do not change the dose of your pain relief medication without talking to your doctor first.

Also, pain medications should never be shared with anyone else. Only your health care professional can decide if a prescription pain medication is safe for someone.

Here are other key points to remember.

With acetaminophen:

  • Taking a higher dose than recommended will not provide more relief and can be dangerous.
  • Too much can lead to liver damage and death. Risk for liver damage may be increased in people who drink three or more alcoholic beverages a day while using acetaminophen-containing medicines.
  • Be cautious when giving acetaminophen to children. Infant drop medications can be significantly stronger than regular children’s medications. Read and follow the directions on the label every time you use a medicine. Be sure that your infant is getting the infants’ pain formula and your older child is getting the children’s pain formula.

With NSAIDs:

  • Too much can cause stomach bleeding. This risk increases in people who are over 60 years of age, are taking prescription blood thinners, are taking steroids, have a history of stomach bleeding or ulcers, and/or have other bleeding problems.
  • Use of NSAIDs can also cause kidney damage. This risk may increase in people who are over 60 years of age, are taking a diuretic (a drug that increases the excretion of urine), have high blood pressure, heart disease, or pre-existing kidney disease.

With opioids:

  • Use of opioids can lead to drowsiness. Do not drive or use any machinery that may injure you, especially when you first start the medication.
  • The dose of an opioid pain medication that is safe for you could be high enough to cause an overdose and death in someone else, especially children.

 

KNOW THE ACTIVE INGREDIENTS

A specific area of concern with OTC pain medicines is when products sold for different uses have the same active ingredient. A cold and cough remedy may have the same active ingredient as a headache remedy or a prescription pain reliever.

To minimize the risks of an accidental overdose, consumers should avoid taking multiple medications with the same active ingredient at the same time.

All OTC medicines must have all of their active ingredients listed on the package. For prescription drugs, the active ingredients are listed on the container label.

Talk with your pharmacist or another health care professional if you have questions about using OTC medicines, and especially before using them in combination with dietary supplements or other OTC or prescription medicines.

MISUSE AND ABUSE

Misuse and abuse of pain medications can be extremely dangerous. This is especially so in regard to opioids. These medications should be stored in a place where they cannot be stolen.

According to the National Institutes of Health, studies have shown that properly managed medical use of opioid analgesic compounds (taken exactly as prescribed) is safe, can manage pain effectively, and rarely causes addiction.

But the abuse of opioids is a significant public safety concern. Abusers ingest these drugs orally, and also crush the pills in order to snort or inject them.

Commonly abused opioid pain medicines include prescription drugs such as codeine, and the brand-name products Oxycontin (oxycodone), Vicodin (hydrocodone with acetaminophen), and Demerol (meperidine).

Addiction is just one serious danger of opioid abuse. A number of overdose deaths have resulted from snorting and injecting opioids, particularly the drug OxyContin, which was designed to be a slow-release formulation.

USE OPIOIDS SAFELY: 3 KEY STEPS

  1. Keep your doctor informed. Inform your health care professional about any past history of substance abuse. All patients treated with opioids for pain require careful monitoring by their health care professional for signs of abuse and addiction, and to determine when these analgesics are no longer needed.
  2. Follow directions carefully. Opioids are associated with significant side effects, including drowsiness, constipation, and depressed breathing depending on the amount taken. Taking too much could cause severe respiratory depression or death. Do not crush or break pills. This can alter the rate at which the medication is absorbed and lead to overdose and death.
  3. Reduce the risk of drug interactions. Don’t mix opioids with alcohol, antihistamines, barbiturates, or benzodiazepines. All of these substances slow breathing and their combined effects could lead to life-threatening respiratory depression.

KurzweilAI.net is Pleased to Announce:

The 13th Annual Sonoma International Film Festival will host a sneak preview of:

“The Singularity is Near: A True Story about the Future” film based on Ray Kurzweil’s best-selling book screens at Sonoma International Film Festival on Friday, April 16, 2010

THE SINGULARITY IS NEAR: A TRUE STORY ABOUT THE FUTURE, by filmmakers Anthony Waller, Ray Kurzweil, Ehren Koepf and Toshi Hoo, with Executive Producer Martine Rothblatt (Terasem Motion InfoCulture), makes its festival debut at the 13th Annual Sonoma Film Festival (April 15-18, 2010) with a special screening on Friday, April 16, 2010. 

ABOUT THE FILM The compelling feature-length documentary film, directed by Anthony Waller, written by Ray Kurzweil, and produced by Ray Kurzweil, Ehren Koepf and Toshi Hoo, explores the controversial ideas of luminary Ray Kurzweil, based on his New York Times best-selling book by the same title. For more than three decades, inventor, futurist, and author Ray Kurzweil has been one of the most respected and provocative advocates of the role of technology in our future.

The film presents the daring arguments from Kurzweil’s book, The Singularity is Near. He predicts that with the ever-accelerating rate of technological change, humanity is fast approaching an era in which our intelligence will become increasingly merged with computers and trillions of times more powerful. This will be the dawning of a new civilization, enabling us to transcend our biological limitations. In Kurzweil’s post-biological world, boundaries blur between human and machine, real and virtual. Human aging and illness are reversed, world hunger and poverty are solved, and we cure death. He maintains a radically optimistic view of the future course of human development while acknowledging new dangers.

Kurzweil examines the social and philosophical implications of these profound changes and the potential threats they pose to human civilization in dialogues with world leaders, such as former White House counter-terrorism advisor, Richard Clarke; technologists Bill Joy, Mitch Kapor, Marvin Minsky, Eric Drexler, and Robert A. Freitas, Jr.; Future Shock author Alvin Toffler; civil liberties lawyer Alan Dershowitz; and music luminary Quincy Jones. Kurzweil illustrates possible scenarios of his imagined future with narrative scenes starring popular NCIS actress Pauley Perrette and personal development guru Tony Robbins. THE SINGULARITY IS NEAR offers a view of the coming age that is both a dramatic culmination of centuries of technological ingenuity and a genuinely inspiring vision of our ultimate destiny.

For more information about the film visit: Singularity.com/themovie 

 

 

SONOMA INTERNATIONAL FILM FEST SNEAK PREVIEW SCREENING THE SINGULARITY IS NEAR will debut Friday, April 16th, 6:30 p.m. at the Sebastiani Theater (323 seats), located at 476 First Street East (“on the plaza”), Sonoma, CA 95476. A discussion with Ray Kurzweil and Cevin Cathell, SIFF Program Director, will immediately follow the screening. 

 

 

TICKETS AND PASSES Passes to Festival screenings are available online now at Sonomafilmfest.org or by phone at 707.933.2600. For more information: Sonomafilmfest.org

 

 

ABOUT SONOMA INTERNATIONAL FILM FESTIVAL The Sonoma Film Festival, now in its 13th year, is set amidst the unparalleled beauty of the Sonoma Valley wine country. This year’s festival runs April 15-18th with more than 64 new independent films from around the world. Film presentations at a variety of venues including the historic Sebastiani Theater on the Sonoma Town Plaza will include: world cinema, feature length narratives, documentaries, shorts and a student film program. Documentaries have seemingly become one of Sonoma’s specialties, having previously shown the groundbreaking Food Inc. and this year’s Academy Award winner, The Cove. For more information: Sonomafilmfest.org

 

 

CONTACT

For more information contact:

Sarah Reed, Public Relations Manager, Kurzweil Technologies SReed@Kurzweiltech.com

781-263-0000