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A story that was virtually ignored by the mainstream press and disappeared almost without a trace has to do with serious allegations against Ranbaxy Laboratories, an Indian drug company. Ranbaxy is not just any drug company. It is the largest pharmaceutical company in India, by sales. The company has huge sales around the world, thanks in large measure to its dominance in the generic drug arena. Not surprisingly, Ranbaxy sells a LOT of meds in the U.S.
According to reports, Justice Department investigators are concerned that Ranbaxy may have submitted false claims, fabricated documents and committed fraud in drug submissions to the FDA.
Congress is getting into the act. Leaders of the House Committee on Energy and Commerce have put the FDA on the hot seat, raising questions about what FDA staffers knew about this and when they knew it. There are court documents suggesting that FDA has been aware of trouble at Ranbaxy for at least 18 months. FDA apparently did nothing to warn physicians, patients or pharmacists of the suspected problems.
If Ranbaxy fabricated evidence for its generic drug applications to the FDA and concealed violations of manufacturing practices, this is a big deal. We have been questioning the ability of the FDA to monitor the quality of generic drugs for several years. (Read some of the reports on this site for frightening examples of apparent generic shortcomings.) We suspected that some companies in China and India may have taken short cuts. If the Ranbaxy mess proves true, we will know that our fears were justified. We wonder how many other problems may not have been detected by the FDA.
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My blood pressure had been maintained at good level for several years. My national chain pharmacy was bought out by another national pharmacy. Had blood pressure generic"enalapril" and generic
diuretic "indapamide" refilled there.
Soon I began retaining fluid and had increased blood pressure readings. Switched to a small, local pharmacy. The generic diuretic was from a different supplier and it slowly began to work. However, the "enalapril" was not successfully keeping blood pressure down.
Began having "auras" and more fluid retention. Then I purchased [at my expense] brand Vasotec for blood pressure. It slowly began working. After one month the Medicare Part D insurer said I need to use generic Vasotec. I did [and this time it was manufactured by Ranbaxy, which I was assured, was a very good company.] Again, the fluid began building up and blood pressure increased.
The Part D insurer again turned down the doctor's request for Vasotec, and again I paid for it out of pocket. Then, the Insurer "prescribed" another kind of ACE blood pressure medication. Apparently I have to follow the Insurer's "prescriptions" to prove or to disprove their beneficial worth for me.
At the end of this "trial and error" I have no idea of what will happen. I feel that I am in a clinical drug trial with no oversight, no compensation and most importantly: no real concern for the good of the patient. Of one thing I am sure: the enalapril by Ranbaxy was not working. And today I will pick up
the brand Vasotec, which I will have paid a "few" hundred dollars for in these non-insured prescriptions. And, yes, I monthly pay
Medicare Part D insurer.
AS a practicing physician and former active pharmacist, I see patients with many chronic health care problems. Generic drugs have become a haven for scam artists and now manufacturing firms as a get rich quick scheme; the unsuspecting public believes the FDA monitors generic companies as they do the branded drug houses; there is a world of difference.
Unfortunately I am now told pharmacists get bonus money in converting a patient to a generic product when they know nothing about its effect; apparently this is BIG money for the large retail stores. This is unethical and proves a doctors patient has become a pharmacists customer, nothing more than a cash register slip.
Until a pharmacist has no incentive to promote substandard generics more patients will be at risk getting inadequate medication to inadequately treat their chronic, sometimes, life threatening problems. Pharmacists are highly trained but corporate America has reduced them to clerks.The "practice" of pharmacy has died.
Ranbaxy is in the news again on Sept 17 2008. FDA has issued 2 warning letters and may ban their generic drugs.
I am glad the FDA may finally be taking some action, but I am quite dismayed at all the reports I have just read online, concerning generic drugs and their effectiveness, how they are falling so short of quality control. I have been through a dreadful month myself, when I was switched to two different generics, that seem to do nothing close to the one I had previously been taking; I suspect they are weaker version or even frauds.
I also am on Medicaid and Medicare plans; I am on disability for this very difficult to manage painful condition, known as Interstitial Cystitis. I was leading a fairly normal life, with symptoms basically controlled, until I experienced what I am now going through, which is horrific. I can hardly leave the house for any length of time and now have to resort to stronger pain relievers such as Percocet.
I can't drive anywhere on the drug and feel so incapacitated. I have discussed this problem with my doctor and she is trying to get me the brand name drug, but that is a long shot, I know. I even broke out in a rash with one of the generics I tried; this may aid my request. I am desperate now to get my life back on track. I am suffering needlessly and can't sleep at night because of bladder frequency and pain. As a result my blood pressure is higher and my nerves are on edge.
I have a few questions. Is it better to go to a small pharmacy, than to a large chain pharmacy? After reading some of the above entries, I felt it might be an answer, but I am still not sure. I have thought of changing to a small one, near my home, run by a very nice and responsible family. I also want to know how one can find out the 'inactive' ingredients in the generic drugs. My pharmacy chain, CVS, claims they are not privy to that information. My third question would be how can one find out the original source of the generic drug one is taking? I know that many of the drug companies, here in the US are now importing, as your article states.
I will further pursue this issue and if need be I will write articles/letters to support what you are trying to do on your blog and your website. bringing this to the public eye is one step in the fight. I commend you on this action and will sign any petitions for further intervention into this problem with the FDA.
Thanks so much for posting all of these reports. I will print them out to show my doctor and my pharmacy.
Right now I just want my life back.
In today's paper I see news of a new "polypill" to treat heart disease.
It is made in India. This really gives me the creeps given recent concerns with one Indian drug producer's reliability and contamination of a blood thinner product.
If one fears, already, proprietary or generic drugs from India, or another foreign country, such a combination as the polypill can create a sort of Frankenstein-ian concern.
At a gulp, one could take more than four or more drugs and only wonder about their possibly multiple problematic interactions and whether any of the drugs are what they purport to be anyway !!
The FDA, in my opinion,
cannot deal adequately with its present mission. How, then, will it deal with all the variables in this most recent experiment??
The FDA's' inadequacies continue to threaten us all. We need to protest to our representatives about this violation of the Public's trust and call for the remediation of it.
The information shared is correct. Generic drugs are absolutely a case of medical scams that the FDA, cannot manage. Taking generics is risky at best, but insurers have made it almost impossible for patients to fill their scripts with branded products. You may be certain, pharmacies are purchasing their generics from the supplier that gives them the best price. The patient's RX may be filled with Brand A one month and Brand B the following month. The FDA allows a bioavailability range of 80-125% for generic drugs. Hence the differences in response experienced by patients taking generics.
The FDA insists generics are monitored closely, and their confidence interval is the same as branded products. Absolutely not true! They are not monitored, they do differ, and they can be dangerous. The FDA relies on the "honor system" regarding generic manufacturers, and that is like the fox minding the henhouse. Branded products are subject to stringent quality controls and their bioavailability difference does not exceed 5-8% of the allowable range.. Any drug that is an NYI drug (narrow therapeutic index) should be filled with a branded product and reimbursed by insurers. Coumadin/warfarin is certainly one of those NTI drugs. Unfortunately, patient safety is not a something generic manufacturers consider. The FDA is toothless. They are incapable of monitoring the industry and patients are experiencing the consequences of generic medications.
The only way to possibly counter the generic mess is if the pharmaceutical companies manufactured their own generics when the patent on a branded product expires. However, that is not profitable for an industry who’s direct to consumer advertising exceeds a billion dollars each year! So, patients remain at the mercy of generic manufacturers.
I take Zoloft. When the local pharmacy switched me (unknowingly) to generic
after about a week on generic, the symptoms of depression started coming back. I could not figure out why until I looked at my prescription bottle and saw that it had been filled with generic.
The same thing happened with Mobic, when they substituted generic. It was like taking a sugar pill. It did nothing for pain!!!!
I get so irked when the pharmacy automatically substitutes generic without
first asking me, the patient!!
I am a pharmacist with 40 years of prctice. I am very disturbed about the generic drugs which are coming into this country from who knows where. Unfortunately, we have little choice in choosing a generic or a brand name. This is dictated by the insurance company.
When your prescription is filled an electronic claim is sent to your insurance company. The drug is indentified by its national drug code (NDC) and if the insurance company does not like the drug that is submitted, they immediately reject the claim. The insurance company is the gate-keeper through their rejection process.
The FDA considers the country of origin to be confidential information. In many cases I cannot even tell where the drug was manufactured to advise patients. I find this outrageous. Every consumer has a right to know where his drugs are made. We need a consumer uprising over this. Contact your representative and make him aware of this travesty.