The Secret Relationship of Medical Researchers and Pharmaceutical Companies

Finally, congress is investigating the giant pharmaceutical company’s corrupt research practices.  In the drug business, promoting health and safety should be priority number one.  Unfortunately, it is merely a distant second.  In the pharmaceutical industry, making money supersedes science. Some even go as far as claiming that drug makers have become a billion dollar empire not because of research and science, but rather from slick marketing and deceit.  This claim has some validity since the drug companies spend almost twice as much on the marketing of their drugs then on the development of their drugs.

 Some also argue that many drugs are over-prescribed, and that drug companies’ huge profits are often spent developing and advertising expensive designer drugs (such as Viagra) instead of life-saving medications. But now, even the effectiveness of the drugs is being called in to question by the on going congressional inquiry.  Presently, Congress is learning that the drug makers have paid millions of dollars in cash and other benefits to the very doctors who are supposed to be independently testing these drugs.  Rarely will such a doctor bite the hand that feeds them.  Even more insidious, the drug companies employ thousands of foreign-born chemists who are in the US on a work visa.  Their career allows them and their family the right to live and work in the U.S.  This demands allegiance to their employer and many suspect that end result of their research reflects this allegiance.

Perhaps the most alarming discovery of the investigation however points towards the work of Dr. Joseph Beiderman.  Dr Beiderman, one of the world’s most renowned child psychologists at the Harvard Medical School, apparently failed to report to Harvard University that he had received at least $1.4 million in personal income from drug companies.  It was also found that Dr. Biederman had asked a Johnson & Johnson subsidiary to provide him with almost $1 million to start a research center to, “move forward the commercial goals of J.& J.” As a front-runner in the field of psychology, Biederman was responsible for introducing a new era of using powerful, risky, and expensive antipsychotic medicines in young people. 

Hopefully, the present congressional investigation will lead to reforms for the pharmaceutical industry.  One reform would be to break the financial relationship and dependence of the medical profession to drug makers.  Others would be to hold drug makers accountable in a court of law for false advertising and marketing of drugs that harm patients.  The recent vioxx civil trials, which resulted in huge verdicts against the drug makers, is just one example of how effective this system works.  After a few juries heard the truth about this drug maker, and awarded appropriate damages, the vioxx maker quickly settled all the claims against it.  That result sent a strong message to the drug makers that they will be held accountable for deceit in the pursuit of profits.  Hopefully, congress will enact stricter and further reforms as well.  This will allow all of us to have confidence that the medicine we pay for and use has been fairly and legitimately tested by independent doctors and are benefiting our long term health. 

Morphine, Dextroamphetamine, and Isosorbide added to the Ethex Recall

The Ethex Corporation has added three new drugs to its list of recently recalled products.  After Ethex discovered that their propafenone tablets were over-sized, it became evident that many other drugs being manufactured by the company were also over-sized. 

Isosorbide

Isosorbide is a drug used principally in the treatment of angina. It works by dilating the blood vessels in order to reduce blood pressure. All of the recalled Isosorbide Mononitrate tablets said they were 60mg on the bottle and were made by the ETHEX Corporation with expiration dates ranging from 12/2008 and 11/2009.

Recalled lot numbers: 63466, 66034, 67351, and 67354

Dextroamphetamine

Dextroamphetamine is a stimulant used to increase energy and decrease appetite.  The recalled Dextroamphetamine Sulfate came in 10mg pills with expiration dates ranging from 6/2009 to 5/2007. All were made by the ETHEX Corporation.

Recalled lot numbers: 73934, 75892, 77945, 81137, 86320.

Amphetamines are very dangerous drugs, especially when taken in excessive doses. If the batch number on your pill bottle matches any of the above recalled Dextroamphetamine batch numbers you should contact your doctor and/or pharmacists immediately.

Morphine

Two strengths of immediate release Morphine Sulfate and one strength of extended release Morphine Sulfate were recalled, all of them tablets made by the ETHEX Corporation. The two recalled Morphine immediate release pills were 15mg and 30mg. The recalled Morphine extended release pills were 15mg.  The recalled tablets come from any of the following lots with expiration dates ranging from 8/2009 to 3/2011.

Recalled Lot Numbers:

15mg Extended Release Morphine – 81175, 82514-16, 89660, 89664, 89667, 90249-51, 91687
15mg Immediate Release Morphine – 77852-54, 81746, 82519-20, 84113, 90276-78
30mg Immediate Release Morphine – 75093, 77855-57, 82297, 82521-22, 87239, 88925, 90288-98

Morphine is a highly potent and addictive drug in the opiate family. Like other opioids, such as heroin, morphine acts on the central nervous system to relieve pain. Morphine is highly addictive. Tolerance, physical and psychological dependence develops very rapidly. Overdosing on Morphine is very dangerous and can result in severe side effects, including death.

 If you or anyone you know is prescribed any of these drugs, please immediately check the manufacturer and lot number on your pill bottle.  Contact your physician immediately.  Even in the case that you don’t think you have a recalled prescription; call your pharmacy and physician to confirm. 

 If you or a family member has been hurt by any of the Ethex Corporation recalled drugs, please contact an attorney immediately.  You may be entitled to compensation. 

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DRUG ALERT : Ethex Corporation Recalls Overdosed Propafenone Tablets

As first reported on November 11th, there has been a Propafenone recall by the ETHEX Corporation because the pills may have been oversized, which could result in overdose of the drug Propafenone.

Three different strengths were recalled, all of them Propafenone HCI tablets made by the ETHEX Corporation. They were 150mg, 225mg and 300mg pills from any of the following lots with expiration dates ranging from 6/2009 to 3/2011.

Below are the recalled lot numbers:

150 mg – 73761, 78184, 79373, 81240, 81241, 81242, 83470, 84357, 90525, 90526
225 mg – 71720, 74831, 76014-15, 81243-45, 89731, 90527-29, 90657
300mg – 72834, 76016-18, 81246, 89092, 89732, 90530, 90532, and 91641-42

The 150 mg Propafenone Hydrochloride pills are white, scored round film coated tablets with “ETH” on one side and “331? with a bisect on the reverse. The 225 mg Propafenone Hydrochloride pills are white, scored round film coated tablets with “ETH” on one side and “332? with a bisect on the reverse. The 300 mg Propafenone Hydrochloride pills are white, scored round film coated tablets with “ETH” on one side and “333? with a bisect on the reverse. Life threatening consequences of overdosing on Propafenone Hydrochloride includes heart arrhythmias (irregular heartbeat) and dangerously low blood pressure.

If you or someone you know is prescribed Propafenone, please call your physician immediately.An overdose of this substance is very serious, and can cause severe harm.

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FDA Alert: Risk of rhabdomyolysis when simvastatin is used with amiodarone

The FDA issued the following MedWatch Alert today regarding simvastatin used in combination with amiodarone.  The alert reads as follows:

FDA notified healthcare professionals of the risk of muscle injury, rhabdomyolysis, which can lead to kidney failure or death, when simvastatin is used with amiodarone. This risk is dose-related and increases when a dose of simvastatin greater than 20 mg per day is given with amiodarone. Although a revision of the simvastatin labeling in 2002 described an increased risk of rhabdomyolysis when amiodarone is taken with simvastatin doses greater than 20 mg daily, FDA continues to receive reports of rhabdomyolysis in patients treated concurrently with amiodarone and simvastatin. Prescribers should be aware of the increased risk of rhabdomyolysis when simvastatin is prescribed with amiodarone, and they should avoid doses of simvastatin greater than 20 mg per day in patients taking amiodarone.

Read the complete MedWatch safety summary, including links to the FDA Drug Information page, Information for Healthcare Professionals sheet, and labels (Prescribing Information) for simvastatin and amiodarone products, at
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Simvastatin

 

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Voluntary Recall of Viapro 375mg Capsules Due To A Potentially Harmful Analog Of Sildenafil

The FDA, in conjunction with EG Labs LLC has issued a voluntary recall of the popular erectile dysfunction drug, Viapro.  The MedWatch annoucment is as follows:

EG Labs, LLC, notified consumers and healthcare professionals not to buy or use Viapro 375mg Capsules because one lot of the product was found to contain a potentially harmful undeclared ingredient, thio-methisosildenafil, an analog of sildenafil, a FDA approved product used to treat erectile dysfunction in men to enhance sexual performance. The undeclared ingredient may interact with nitrates found in some prescription drugs (such as nitroglycerin) and can lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take products containing nitrates. Consumers who have this product should discontinue using it and consult their healthcare professional if they experience any problems that may be related to taking Viapro.

Read the entire 2008 MedWatch Safety summary, including a link to the manufacturer’s Press Release regarding this issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Viapro

For further information on this recall or to speak to a defective drug attorney, call (856) 833-0600 in NJ or (215) 567-2380 in PA, or fill out the form on the left side of the page.

FDA Officials Get Performance Bonuses for Salmonella, Toxic Dog Food and Heparin?

In a surprising report drafted for the House Energy and Commerce Committee, $35 million in bonuses were paid out in 2007 to top FDA officials– which is a 29% increase from the previous year.

My question is, what part of the FDA’s performance in 2007 was bonus worthy?  Was it the toxic dog food that killed hundreds of pets (take a look at pure balance food review for more on this tragedy and how to avoid it by dealing with a reputable supplier) or the lead paint toys sold to small children as a result of shoddy inspections?  Or maybe it was the contaminated Heparin from China that has been linked to 81 deaths and 700 injuries nationwide?

In the real world (meaning the world outside of “big pharma”), that kind of job performance or track record would have led to pay deductions, if not job termination a long time ago.  To award performance bonuses for such negligence and carelessness is just absurd in my opinion.

Clearly the $35 million in bonuses would have been better spent on plant inspectors or scientific researchers that can catch dangerous drugs before they hit the market.  Instead, our health is put on the back burner so that top FDA officials can be compensated for all of their “hard work.”

Thankfully, the House Energy and Commerce Committee is investigating this ridiculous bonus system, especially since the FDA continues to cry poor when asked about the safety blunders of 2007.  It’s time for someone (anyone at this point) to step in and whip the FDA back into shape—our health depends on it!

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Are you using one of the “8 Drugs Doctors Would Never Take”?

A very interesting survey conducted by Men’s Health magazine reveals which drugs doctors would avoid if given the choice.  It seems to me that if doctors are steering clear of these drugs, consumers should also reconsider using such products.

The following snipit reveals which drugs doctors would skip and their reasons for doing so:

Advair– It’s asthma medicine . . . that could make your asthma deadly. Advair contains the long-acting beta-agonist (LABA) salmeterol. A 2006 analysis of 19 trials, published in the Annals of Internal Medicine, found that regular use of LABAs can increase the severity of an asthma attack. Because salmeterol is more widely prescribed than other LABAs, the danger is greater — the researchers estimate that salmeterol may contribute to as many as 5,000 asthma-related deaths in the United States each year. In 2006, similarly disturbing findings from an earlier salmeterol study prompted the FDA to tag Advair with a “black box” warning — the agency’s highest caution level.

Avandia– Diabetes is destructive enough on its own, but if you try to control it with rosiglitazone — better known by the brand name Avandia — you could be headed for a heart attack. Last September, a Journal of the American Medical Association (JAMA) study found that people who took rosiglitazone for at least a year increased their risk of heart failure or a heart attack by 109 percent and 42 percent, respectively, compared with those who took other oral diabetes medications or a placebo. The reason? While there have been some reports that Avandia use may cause dangerous fluid retention or raise artery-clogging LDL cholesterol, no one is sure if these are the culprits. That’s because the results of similar large studies have been mixed. So the FDA has asked GlaxoSmithKline, the maker of Avandia, to conduct a new long-term study assessing users’ heart risks. There’s only one problem: The study isn’t expected to start until later this year.

Celebrex– Once nicknamed “super aspirin,” Celebrex is now better known for its side effects than for its pain-relieving prowess. The drug has been linked to increased risks of stomach bleeding, kidney trouble, and liver damage. But according to a 2005 New England Journal of Medicine study, the biggest threat is to your heart: People taking 200 mg of Celebrex twice a day more than doubled their risk of dying of cardiovascular disease. Those on 400 mg twice a day more than tripled their risk, compared with people taking a placebo.  And yet Celebrex, a COX-2 inhibitor, is still available, even though two other drugs of that class, Bextra and Vioxx, were pulled off the market due to a similar risk of heart damage. The caveat to the consumer? In 2004, the FDA advised doctors to consider alternatives to Celebrex.

Ketek–  Most bacteria in the lungs and sinuses don’t stand a chance against Ketek, but you might not either. This antibiotic, which has traditionally been prescribed for respiratory-tract infections, carries a higher risk of severe liver side effects than similar antibiotics do. “Ketek can cause heart-rhythm problems, can lead to liver disease, and could interact poorly with other medications you may be taking,” says Dr. Rodgers. “Unfortunately, it’s still available, and although many doctors are aware of the risks, some may still prescribe it without caution.” In February 2007, the FDA limited the usage of Ketek to the treatment of pneumonia.

Prilosec and Nexium– Heartburn can be uncomfortable, but heart attacks can be fatal, which is why the FDA has investigated a suspected link between cardiac trouble and the acid-reflux remedies Prilosec and Nexium. In December 2007, the agency concluded that there was no “likely” connection. Translation: The scientific jury is still out. In the meantime, there are other reasons to be concerned. Because Prilosec and Nexium are proton-pump inhibitors, they are both incredibly effective at stopping acid production in the stomach — perhaps too effective. A lack of acid may raise your risk of pneumonia, because the same stuff that makes your chest feel as if it’s burning also kills incoming bacteria and viruses. You may also have an elevated risk of bone loss — in the less acidic environment, certain forms of calcium may not be absorbed effectively during digestion. “The risk of a fracture has been estimated to be over 40 percent higher in patients who use these drugs long-term, and the risk clearly increases with duration of therapy,” says Dr. Rodgers.

Visine Original– What possible harm to your peepers could come from these seemingly innocuous eyedrops? “Visine gets the red out, but it does so by shrinking blood vessels, just like Afrin shrinks the vessels in your nose,” says Thomas Steinemann, M.D., a spokesman for the American Academy of Ophthalmology. Overuse of the active ingredient tetrahydrozoline can perpetuate the vessel dilating-and-constricting cycle and may cause even more redness.

Pseudoephedrine– Forget that this decongestant can be turned into methamphetamine. People with heart disease or hypertension should watch out for any legitimate drug that contains pseudoephedrine. See, pseudoephedrine doesn’t just constrict the blood vessels in your nose and sinuses; it can also raise blood pressure and heart rate, setting the stage for vascular catastrophe. Over the years, pseudoephedrine has been linked to heart attacks and strokes. “Pseudoephedrine can also worsen symptoms of benign prostate disease and glaucoma,” says Dr. Rodgers.

The full article in Men’s Health can be found here.  The best advice for consumers is to do your homework and talk to your doctor about any side effects you may be experiencing.  In some cases, the benefit of these drugs outweighs the risk; but for the majority of indviduals, these drugs are dangerous and unnecessary.

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Chantix Carries Serious Risks for Users, Banned Among Pilots and Truck Drivers

The smoking cessasion drug, Chantix, has come under fire this month after reportedly causing 988 serious injuries among users.According to a study published by the Institute for Safe Medicine Practices, the 988 injuries were recorded in Pfizer’s fourth quarter alone—which was more than any other drug during that time period.

The reported side effects of Chantix include the following:

  • Suicide or Suicidal thoughts
  • Aggression and hostility
  • Accidents and Falls
  • Life threatening cardiac rhythm disturbances
  • Severe skin reactions
  • Seizures
  • Diabetes
  • Psychosis
  • Acute myocardial infarction

As a result of these severe side effects, the Federal Aviation Administration and Federal Motor Carrier Safety Administration have banned all pilots, air traffic controllers and truckers from using the drug. Unfortunately, The FDA and Pfizer continue to insist that the benefits in the area of smoking cessation outweigh the potentially fatal risks associated with Chantix.

I would encourage patients who have experienced side effects after using Chantix to immediately file a report with the FDA. The online reporting form can be found at: http://www.fda.gov/medWatch/report/consumer/consumer.htm

Similarly, if you have experienced any of the side effects listed above, you may have a case against the drug manufacturer for your injuries. If you wish to discuss your rights, call (856) 833-0600 in New Jersey or (215) 567-2380 in Pennsylvania or fill out the form on the left side of the page.You will be contacted by our nurse within 24 hours.

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Sen. Arlen Spector Sharply Criticizes the FDA

Senator Arlen Spector has sharply criticized the FDA for failing to ask for more funding beyond that which was requested by President Bush in this year’s budget.  Apparently, the FDA was hesitant to reveal their true financial needs because of an administrative rule that forbids any public disagreement with the budget.  As a result, the FDA has become ineffective at policing food and drug supplies– as shown by the recent influx of tainted heparin, dog food, salmonella tomatoes, and lead paint toys.

Sadly, after months of public outrage regarding the failures listed above, FDA officials finally began to drop hints concerning their true financial needs.   They further attempted to thwart the public outrage by blaming Congress for their dragging their feet regarding their untimely $275 Million request.  This week, representatives of the FDA told reporters that they “would like to once again strongly urge Congress to act quickly to enhance the safety of food and medical products.”

However, correcting the record regarding the FDA’s own failure to act was Senator Arlen Spector, who hand wrote a letter to HHS Secretary Michael Levitt stating, “I am really surprised by your comment quoted in the NY Times today urging Congress to act quickly when the Administration is drastically hindering NECESSARY IMMEDIATE RELIEF by delaying the funding for 8-9 months.  The FDA NEEDS this money now to save lives.”

I’m glad Sen. Spector publically exposed the FDA’s inefficiency as an agency designed to protect the American public from dangerous food and drugs.  If they can’t handle making budget requests or making sure that they have the necessary capital to operate effectively, then its clear they can not be trusted with our health and safety.  We can only hope that this open criticism from Sen. Spector will put the pressure on the FDA to shape up and take their job of policing imports and dangerous products seriously.

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Drug Recall: Morphine Sulfate 60 Mg Extended Release Tablets

The FDA has issued a recall today for morphine sulfate tablets because a certain batch was found to contain double the dosage as found in a single pill.  The warning from the FDA is as follows:

ETHEX Corporation notified health care professionals of a voluntary recall of a single lot of morphine sulfate 60 mg extended release tablets (Lot No. 91762) due to a report of a tablet with twice the appropriate thickness. Oversized tablets may contain as much as two times the labeled level of active morphine sulfate. The lot was distributed by ETHEX Corporation under an “ETHEX” label between April 16th and April 27th of 2008. Opioids such as morphine have life-threatening consequences if overdosed. Consequences can include respiratory depression (difficulty or lack of breathing), and low blood pressure. Many patients for whom this product is prescribed are likely to be highly debilitated with reduced strength or energy as a result of illness, and may be less likely to determine that a tablet is overweight or oversized than an unimpaired individual. If consumers have any questions about the recall, they should call their physician, pharmacist, or other health care provider.

Read the MedWatch 2008 safety summary, including a link to the firm’s press release regarding this issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Morphine

This “double thickness” issue also prompted the massive Digitek recall earlier this year.  The heart drug was recalled after a wide range of disturbing side effects were noted in patients, including low blood pressure, reduced heart rate and death.

Obviously, double coated morphine has the potential to cause similar injuries in users.  If you have noticed any of the side effects listed above after taking morphine, it is extremely important that you file a report with the FDA.

Furthermore, if you have been seriously injured as a result of taking this defective product, you may have rights against the drug manufacturer. To speak with a defective product attorney, please call (856) 833-0600 in NJ or (215) 567-2380 in PA or fill out the free case evaluation form on the left side of the page.
You will be contacted immediately for a free case evaluation.