Data base symptoms and conditions

Was on Lipitor 2 years ago and had to come off because of side effects - sever muscle pain.. Prescribed Niaspan instead .. 2 months ago my cholesterol rose to 7.1 and my doc put me straight back on Lipitor - 10mg.. Feeling lousy - neck pain, leg pain, dizziness, fatigue ... head feels fuzzy all the time and get sudden twinges in my chest.. Had stress test done last week and all ok.. Also have severe digestive problems. Going to wait until 2 full months done and going to get bloods done again

Hi
My name is L. H. and I am a medical reporter for teh ABC station in Tampa. I am looking for a family in the Tampa Bay area who is experiencing night terrors or other symptoms from Singulair. Can you contact me if you are in driving distance? ******

thanks
L. H.
******

In my opinion, we shouldn't blame doctors for what they are not told about medications.

We know definitely that work was being done on genetic profiling of children with asthma. We know definitely that the CysLT1 receptor is a gene with variants. We don't know how many different variants. We know that montelukast binds with high affinity to the gene type used in the research studies that lead to it's approval as a drug for asthma. We know that montelukast is very specific because it won't even bind to CysLT1 receptor sub-types. Now somebody out there knows whether there are patients, for which it would be impossible for montelukast to be effective because the patient has a gene variant that is different.

We know that Merck had clinical trials acknowledging that there was a genetic component. We know that Hakon Hakonarson had all kinds of legal troubles over his data base of genetic profiles. We know that Merck was interested in his company. So where is the answer about the genetic variants and the ability to predict whether Singulair will be effective for a particular patient? And, where is the answer about what happens when montelukast does not bind to the cysLT1 receptor?

Hakonarson testifies deCODE loses partnerships because Stefansson won't share corporate information

A former vice president at deCODE Genetics Inc. testified in U.S. District Court in Philadelphia on Friday that the Icelandic biotech firm has been eager to line up new partnerships with other drug development and research firms, but potential deals have died because the company's chief executive refused to share corporate information with possible partners.

Hakon Hakonarson, who had been the firm's vice president of business development, said deCODE CEO Kari Stefansson wanted to form more development deals with other firms, but was not willing to share enough corporate information for serious negotiations to continue. "Dr. Stefansson was always conservative and somewhat insecure about sending information, even if it was under a confidentiality agreement," said Hakonarson.

deCODE has sued Hakonarson for allegedly stealing trade secrets when he defected from the firm earlier this year to become director of the new Center for Applied Genetics at The Children's Hospital of Philadelphia (CHOP). The center plans to genotype 100,000 children and develop new treatments with private-sector partners.

In its case against Hakonarson and four other former deCODE employees, the company alleges thousands of computer files were stolen from deCODE with the intention of duplicating the company's business model and operations at CHOP in order to compete directly with deCODE. The company is seeking a preliminary injunction to enforce employment contracts that would prevent its former scientists from working at CHOP for two years.

CHOP's lawyer, William Hangley, elicited responses from Hakonarson indicating that earlier this year, deCODE was in need of new outside partners because some key revenue-generating relationships were winding down. An agreement with Roche Diagnostics was set to expire at the end of June, while another clinical trial program with Merck was in effect, but inactive, Hakonarson testified. He also said he had tried to get Cephalon interested in taking a larger role in deCODE.

Bayer was invited to work on clinical trials for a cardiovascular drug, but the deal never happened, Hakonarson testified. Earlier this month, deCODE announced it was discontinuing work on the drug because of problems with the formulation.

Hakonarson said he became alarmed earlier this year when he saw other biotechs forming partnership deals even though he felt deCODE had a superior pipeline. "I felt we had significant resources and we could not get this done because Dr. Stefansson never allowed it to materialize."

Hakonarson's testimony also touched on computer files. A forensic computer expert hired by deCODE to analyze its systems gave earlier testimony that Hakonarson or people using his login identity and password copied at least 46,795 files from the Hakonarson folder on the deCODE home directory. "In all reasonable probability, those files were written to the Western Digital 250GB external hard disk drive or other smaller removable media devices that Hakonarson is known to have used at deCODE," according to a report filed by John F. Ashley, a forensic computer analyst hired by deCODE.

In his testimony, Hakonarson described one case in which he did remove files from deCODE computers. He said he took files related to a presentation about gene chip equipment by Illumina Inc., which provides technology to deCODE, off the company's 30-day open file system in late May or early June after Stefansson had asked him to resign. Hakonarson and Stefansson have both testified that even after Hakonarson announced he would be taking the job at CHOP in February, the two attempted to work out a collaboration in which Hakonarson would also work part-time for deCODE. Eventually those talks broke down and deCODE filed its suit, which was unsealed Sept. 26.

Hakonarson also said he had been in discussions with Cephalon about working as a consultant until he received a letter from deCODE's attorneys this summer. He said the letter contained some inaccuracies, particularly a charge that deCODE first learned about his intention to move to CHOP in July when the center put out a press release. Harkonarson insisted Stefansson knew about his plans in February and said he was concerned the letter was setting him up for legal problems later.

"I was concerned Kari had been as a chess player making valuable moves to go forward," Hakonarson said.

The complex hearings, which have been before Judge Jan E. DuBois since the suit was unsealed, have been closed frequently as the parties discuss parts of the case they contend are confidential. Hearings are scheduled to resume in November.

Susan Warner
mail@the-scientist.com

All credit to Susan Warner and the-scientist

I would like to urge everyone to report adverse drug reactions to the FDA. Without a supporting data base, things move way too slowly and other people get hurt. I was doing some further work on quinolines/quinolones and ran across a medical researcher who starting writing about quinolones in 2001. The warnings that finally appeared on the quinolone drugs were placed in 2005. Let's do everything to keeping that from happening to parents.

Here is the researcher who wrote about quinolones so that you will have the reference.

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In reply to concerned-dad and all others with chronic congestion, etc. I have heard several people that have tried the "Eat Right For Your Blood Type" (in bookstores) with incredible results. Even if they have not followed the most strict food do's/don't for their blood type, and made minimal changes they noticed a dramatic difference with congestion and asthma symptoms in children and adults.

I am not endorsing the book - but I will however give it a good hard try if my daughter's symptoms return that she had prior to being put on Singulair. And yes, you are so right to be concerned with the timing of Singulair and any new behavior issues - I still stand my ground when I say it is NOT normal for a toddler growing up in a loving home to have such horrible night terrors, screaming in fear.

My 4 year old took her last dose 3 weeks ago after a 2 year run on Singulair not an hour has gone by without her dad, sister and I still feeling waves of shock. She has completely changed from an unhappy, moody, unemotional girl into a loving, well-mannered, well-disciplined, even tempered 4 year old. Unfortunately, since the side effects have been so secretly held, all parents have been chalking all the behavioral issues to "toddler" years.

As I wrote to the FDA rep, this would be a classics Deceptive Trade issue for any other company in our country. Quite simply, when Singulair first rolled out it was sold with "ABC" treatments and "XYZ" side effects by the pharm reps. In February the FDA website notes they have given Merck 9 months to investigate (THEMSELVES) the many consistent complaints of side effects received for Singulair. And since the FDA did not give them a time limit to communicate the ongoing investigation and recently added side effects, my pediatrician and pharmacist as of May are still unaware. Same old commercials airing with the original "mild" side effects as sore throat, etc., same pharm reps visiting my doctor without informing of recent changes to the originally selling points.

Had my pediatrician been aware, I would have not received the answer I did when asking her what a toddler could have so horrible in their life to scream and cry through nightmares - "Some children react in their dreams if perhaps they saw a spider earlier in the day that scared them". I figured it would have to be a spider the size of my car to get that kind of nightmare, but in her defense had she been aware of the updated information with Singulair she would have zeroed in on the "bad/vivid dreams" Merck has now added to their website.

Hope this helps someone and if anyone has given the "Blood Type" eating regimen a try would love to hear comments.

I am posting this as a new post. I am not against Singulair. I am against withholding negative side effects from the patients. I am against promoting that Singulair is safe and effective for everybody on the planet.

My entire family is health care. My father was a surgeon. I worked for a pharmaceutical company. Pharmaceutical companies are supposed to ethically invent drugs and inform everybody about the safe and effective way to use those drugs. Pharmacists are supposed to police the prescriptions and dispense the correct dosage. Then pharmacists are supposed to be aware of side effects and drugs interactions. When necessary, pharmacist are supposed to intervene to prevent a mis- communication from turning into a disaster. Doctors are supposed to review the recommendations of pharmaceutical companies (who are policed by the FDA) in order to determine if their diagnosis matches the profile of drugs known to be therapies for certain symptoms. I, personally, am madder than hell at Merck. Singulair could really be a good therapy when it is needed. It could correct some bad stuff that happens short term. Why does Merck's need to make every drug a major block buster money maker ruin the market for Singulair?