"Off Label Use" - Part 2

Topamax

6-months ago, the Judiciary Report wrote a series of articles, beginning on November 19, 2009, regarding the "Off Label Use" of the terrible pharmaceutical drug Topamax and its debilitating effects. "Off Label Use" is a term used when drug companies promote their products for uses other than what they were originally intended and approved for by the government.

Topamax is an epilepsy medication, but doctors, under the instruction of pharmaceutical companies, began prescribing it for other medical conditions, such as migraines, thunderclap headaches, depression and as a diet drug, because they were paid to do so. They greedily marketed it as a cure-all drug to cover a wide range of medical ailments, when it is a dangerous pharmaceutical.

6-months later on Friday, May 21, 2010, Johnson & Johnson, the makers of the drug, Topamax, pled guilty to pushing the pharmaceutical drug Topamax for uses other than what it was approved for by the government, using doctors in pay for play schemes, who then prescribed it to their patients under said inducements. They have agreed to pay over $80 million dollars in government fines.

I was speaking from experience when I wrote those articles last year, as I had a stress induced brain hemorrhage and was prescribed Topamax in 2009, for the headaches and head pains I began to experience after the incident, due to ongoing acute emotional distress and harassment.

I resisted taking the medication, a fact that was noted in my medical records more than once, as based on my significant understanding of pharmaceutical drugs, it did not seem like something someone who had experienced the unprecedented type of brain hemorrhage I did, should be prescribed.

However, a female doctor, who was a trainee at the teaching hospital, got upset during a follow up visit they ordered and demanded I take the medication.

Concerned they would discontinue treatment, while I was still very sick from the hemorrhage and angiogram they botched, leaving me with nerve damage in my right leg, I took the Topamax.

Within two days of doing so, I was as sick as a parrot, due to the Topamax. It was worse than the stress induced brain hemorrhage. I developed a condition known as metabolic acidosis, which is the end result of medication creating an environment in the body that promotes acid in the blood, which is horrible. In essence, it is like blood poisoning.

The first signs of it was a very elevated heart rate, which simulated the feeling of having a heart attack and involuntary hyperventilation, which is the lungs trying to blow off the excess carbon dioxide, thanks to the Topamax.

It reached a crescendo on the day before Thanksgiving last year. I fell asleep and one hour later, was awoken by a terrible pain on my right side that was wrapping around from my back to my ribs and depressing my breathing to the point I had stopped taking in oxygen. In short, I was choking to death in my sleep, with a sharp pain on the right side of my back and ribs, constricting to the point, I could barely move.

When I was finally able to move and stand up, I started breathing again, but when I slowly walked over to a mirror, I noticed I was shaking like a leaf, a term known as "tremors" which was created by the Topamax.

I asked my mom to call 911, as I was concerned I would lapse into a coma and die and the pain in the ribcage constricting my breathing, was still there. It literally hurt to breathe. The ambulance took me to the hospital that originally prescribed the Topamax, after the paramedics noticed the tremors.

The hospital did everything they could to limit liability, realizing I was experiencing a very adverse reaction to the Topamax, an epilepsy drug, they had prescribed to me, someone without epilepsy, who was experiencing headaches and head pains (linger effects of the hemorrhage) and nerve pain in my leg (due to the botched angiogram).

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Science Safety

Scientists Call For Drug Database

Yesterday, scientists called for a drug database, to monitor the effects of individual pharmaceutical drugs on the public. It makes sense and I am in agreement with it. God willing, a database can help prevent medical tragedies.

In the Judiciary Report articles Good And Bad Pharmaceutical Drugs on November 19, 2009 and Off Label Use on November 21, 2009 I made reference to the many complaints I found online regarding the terrible drug Topamax and its generic evil twin Toprimate, whose horrible side effects include Acidosis, as some sites such as www.medications.com currently offer public feedback. In the July 21, 2009 article Celebrity Prescriptions, I also wrote of the need for a comprehensive drug computer system to prevent the abuse of prescription meds.

By and large, most drug makers are not criminally negligent and knowingly releasing bad products, but some are and measures need to be taken to weed out those faulty, potentially deadly medications as soon as possible, since some companies will not police themselves.

Most scientists mean well. When a scientist develops a cure, he or she is not usually thinking of how much money they will make, but how many people's health and lives will be improved.

Public Database Is Urged to Monitor Drug Safety

Published: November 23, 2009 - What could be done to prevent another Vioxx? This pain medication for arthritis became a blockbuster after its introduction in 1999, only to be taken off the market in 2004 when a study linked the drug to an increased risk of heart attack and strokes.

A new study published Monday in Archives of Internal Medicine offers an ambitious proposal to determine a drug’s risks sooner than they might otherwise become evident. The authors propose a system to examine widely prescribed drugs through safety analyses that would pool data as they emerge from various clinical trials of a medication and aggregate the information for a fuller picture of a drug’s harms and benefits.

As policy makers in Washington push for various forms of evidence gathering to determine the safety and effectiveness of medical treatments, the study proposes a broad model for monitoring drug safety that would consist of detailed publicly available data that independent researchers could freely analyze.

Such a database could be continually updated and aggregated with new information, as the results of new studies were published, to calculate a near real-time balance sheet of a drug’s risks and benefits.

Dr. Joseph S. Ross, the lead author of the study, said the objective of the researchers was to determine whether this kind of sequential cumulative analysis could serve as a new model for monitoring the safety of drugs after they enter the market.

“How could we be doing post-market surveillance in a better way?” said Dr. Ross, an assistant professor of geriatrics and palliative medicine at Mount Sinai School of Medicine in Manhattan. “For drugs that we are concerned about, that are high risk, this could be a blueprint going forward.”...

“There is this kind of dogma in medicine that you shouldn’t use any drug for the first seven years after it’s released, because it takes that long to figure out its harms and benefits,” said Dr. Michael Steinman, an assistant professor of medicine at the medical school of the University of California, San Francisco...

http://www.nytimes.com

Good And Bad Pharmaceutical Drugs

Do Not Take Topamax (Topiramate) - It Is Dangerous

Modern medical science has presented the world with quite a few discoveries. Some good, some bad. Take for instance, the Polio vaccine did wonders for many.

The modern pharmaceutical industry sometimes exemplifies the term "trial and error." They often guess and it becomes evident when they run trials on a drug, it fails, then they change the disease or affliction they wish to target (Flibanserin). That's called guesswork.

Ibuprofen is a drug that has helped many with pain relief, with few, if any side effects. It is one of the better pharmaceutical drugs that have been created, which has been well tolerated by many. However, it is not right for everyone, as it can act as a blood thinner.

However, there are some horrific pharmaceutical drugs out there, which create worse side effects than the medical problem they are designed to address.

For example, Topamax, is a terrible pharmaceutical drug. It is meant to target migraine headaches, but many people have reported serious side effects such as blurry vision, blindness, severe depression, hair loss, anxiety, heart palpitations, psychosis, tingling in limbs, trouble finding words when reading, confusion, aggressiveness, fatigue, feelings of dread, loss of appetite, memory loss and in the worst cases, a number of suicides.

Is it worth all that to stop migraines - NO! Topamax has a number of lawsuits against it and deservingly so. What it has done to the health and well being of many is disgraceful.

Neurontin (Gabapentin) is a drug currently embroiled in a number of lawsuits for wrongful death, as it put some patients at a high risk for suicide, resulting in a number of deaths. It also created severe anxiety, shaking, dry mouth, throat pain, fatigue, stomach pains, confusion, kidney stones, hallucinations, dizziness, acidosis, memory loss and heart palpitations in many. It is supposed to target seizures, but is being marketed for other uses such as relief from nerve pain, which is debatable and the treatment of bipolar disorder.

It was recently discovered, pharmaceutical giant, Pfizer, tampered with Neurontin studies. There needs to be transparency regarding Neurontin, as the current lawsuits indicate there is deceptiveness on the manufacturer's part. Consumers don't deserve that.

Tegretol (Carbamazepine) is another drug that has some issues, in that it is meant to target items such as seizures, but it lowers the white blood cell count, which decreases the effectiveness of the immune system. They need to work on that.

When a person is sick, they need the best care available. Conflicts of interest can arise, when some doctors are on a pharmaceutical company's payroll, as has been found in a number of cases.

Some pharmaceutical drug makers mean well, but some are reckless and looking for a profit at any cost, even if it means putting a product on the market that test trials revealed is very dangerous.

It's one thing when a drug company does not know what the side effects and long term effects are, but it is quite another when they do, but rush the product out anyway, killing people, for a quick buck.

Another issue is drug interactions, as quite a few drugs are not meant to be taken in tandem with others. A number of celebrities have overdosed in this manner.

Life and health are so precious. At the end of the day, everyone deserves proper medical care and the best pharmaceutical products available. Drug companies, doctors, nurses and hospitals should bear that in mind when they show up for work, as when you put yourself ahead of the patient, you will fail. Then it becomes about you and not making people better.

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Pfizer Broke the Law by Promoting Drugs for Unapproved Uses

Nov. 9 (Bloomberg) -- Prosecutor Michael Loucks remembers clearly when lawyers for Pfizer Inc., the world’s largest drug company, looked across the table and promised it wouldn’t break the law again.

It was January 2004, and the attorneys were negotiating in a conference room on the ninth floor of the federal courthouse in Boston, where Loucks was head of the health-care fraud unit of the U.S. Attorney’s Office. One of Pfizer’s units had been pushing doctors to prescribe an epilepsy drug called Neurontin for uses the Food and Drug Administration had never approved.

In the agreement the lawyers eventually hammered out, the Pfizer unit, Warner-Lambert, pleaded guilty to two felony counts of marketing a drug for unapproved uses.

New York-based Pfizer agreed to pay $430 million in criminal fines and civil penalties, and the company’s lawyers assured Loucks and three other prosecutors that Pfizer and its units would stop promoting drugs for unauthorized purposes.

http://www.bloomberg.com

Justice eyes marketing at J&J, Forest

November 10, 2009 — 12:23pm ET - It looks as if yet another U.S. drug-marketing investigation is about to be settled. As Dow Jones reports, Forest Laboratories has reached a tentative deal with the feds, which would settle civil allegations that it mismarketed antidepressants and a thyroid drug. But the deal wouldn't cover the government's "ongoing investigation into potential criminal law violations." So Forest isn't exactly out of the woods yet...

Or if you're Johnson & Johnson, you disclose a laundry list of subpoenas from the feds on both coasts, plus grand jury summons, related primarily to the marketing of antipsychotic Risperdal, as well as the seizure drug Topamax and congestive heart failure remedy Natrecor. As In Vivo recounts today, J&J was mentioned in a press release about last week's Justice Department deal with Omnicare, and recent SEC filings detail the many investigations the company is now dealing with. Whether the probes spawn civil and/or criminal settlements remains to be seen.

http://www.fiercepharma.com