AP: Millions Spent On Unapproved Medicines

Analysis Shows Deaths Linked To Drugs Used By Medicaid, But Never Screened By FDA

(CBS/AP)  Dozens of deaths have been linked to medications that have never been reviewed by the government for safety and effectiveness but are still covered under Medicaid, an Associated Press analysis of federal data has found.

Taxpayers have shelled out at least $200 million since 2004 for such drugs, and millions of private patients are taking them as well.

The AP analysis found that Medicaid paid nearly $198 million from 2004 to 2007 for more than 100 unapproved drugs, mostly for common conditions such as colds and pain. Data for 2008 were not available but unapproved drugs still are being sold. The AP checked the medications against FDA databases, using agency guidelines to determine if they were unapproved. The FDA says there may be thousands of such drugs on the market.

The medications date back decades, before the Food and Drug Administration tightened its review of drugs in the early 1960s. The FDA says it is trying to squeeze them from the market, but conflicting federal laws allow the Medicaid health program for low-income people to pay for them.

Medicaid officials acknowledge the problem, but say they need help from Congress to fix it. The FDA and Medicaid are part of the Health and Human Services Department, but the FDA has yet to compile a master list of unapproved drugs, and Medicaid - which may be the biggest purchaser - keeps paying.

"I think this is something we ought to look at very hard, and we ought to fix it," said Medicaid chief Herb Kuhn. "It raises a whole set of questions, not only in terms of safety, but in the efficiency of the program - to make sure we are getting the right set of services for beneficiaries."

At a time when families, businesses and government are struggling with health care costs and 46 million people are uninsured, payments for questionable medications amount to an unplugged leak in the system.

Sen. Charles Grassley, R-Iowa, has asked the HHS inspector general to investigate.

That unapproved prescription drugs can be sold in the United States surprises even doctors and pharmacists. But the FDA estimates they account for 2 percent of all prescriptions filled by U.S. pharmacies, about 72 million scripts a year. Private insurance plans also cover them.

The roots of the problem go back in time, tangled in layers of legalese.

It wasn't until 1962 that Congress ordered the FDA to review all new medications for effectiveness. Thousands of drugs already on the market were also supposed to be evaluated. But some manufacturers claimed their medications were grandfathered under earlier laws, and even under the 1962 bill.

Then, in the early 1980s, a safety scandal erupted over one of those medications. E-Ferol, a high potency vitamin E injection, was linked to serious reactions in some 100 premature babies, 40 of whom died.

In response, the FDA started a program to weed out drugs it had never reviewed scientifically. Yet some medications continued to escape scrutiny.

Sometimes, the medications do not help patients. In other cases, the FDA says, they have made people sicker, maybe even killed them. This year, for example, the FDA banned injectable versions of a gout drug called colchicine after receiving reports of 23 deaths. Investigators found the unapproved drug had a very narrow margin of safety, and patients easily could receive a toxic dose leading to complications such as organ failure.

Critics say the FDA's case-by-case enforcement approach is not working.

"The FDA does not appear to have a systematic mechanism to report these drugs out," said Jon Glaudemans, senior vice president of Avalere Health, a health care industry information company, "and there doesn't seem to be a systematic process by which health insurance programs can validate their status. And everyone is pointing the finger at someone else as to why we can't get there."

In most cases, doctors, pharmacists and patients are not aware the drugs are unapproved.

"Over the years, they have become fully entrenched in the system," said Patti Manolakis, a Charlotte, N.C., pharmacist who has studied the issue. Only a few unapproved drugs are truly essential and should remain on the market, she added.

Tackling the problem is made harder by confusing - and sometimes conflicting - laws, regulations and responsibilities that pertain to different government agencies.

Medicaid officials said their program, which serves the poor and disabled, is allowed to pay for unapproved drugs until the FDA orders a specific medication off the market. But that can take years.

Compare that with Medicare, the health care program for older people.

Medicare's prescription program is not supposed to cover unapproved drugs. Medicare has purged hundreds of such medications from its coverage lists, but continues to find others.

[lf1952]

(1) %u201CAmerican%u201D drug companies?? see http://en.wikipedia.org/wiki/List_of_pharmaceutical_companies
Some are, some aren''t. No difference in behavior.

(2) Pills are checked (by FDA and USP). However: Pharmacists and prescribers DO make mistakes - one advantage of electronic prescribing - reduces errors. If your pills look different, CHECK!

(3) There is NO truth the GM crops concern. I have contact daily with physicians in India.

(4) johnsole1 is almost correct. The FDA does SOME testing, but the drug company must set up and fund all the testing to submit new drugs or indications. I have been an investigator and the way the reporting is set up, they should find any major issues during testing. A lot of what you hear is post marketing experience being used to go back and re-look at data, and then criticize the original analysis. NOT valid!

(5) Just so everyone understands: if a Medicaid patient walks through your door - you have lost money as soon as the receptionist says hello.
If a Medicare patient walks through your door, you can spend about 5 minutes with them before you start losing money. THAT is why many excellent physicians will not see either - they would go bankrupt. The system is broken.

(6) Remember that the drug companies are essentially the ONLY ones doing research on new drugs. If they stop for lack of profit motive, there won%u2019t be any research.

[chloemontague]

STOP GM FOOD AND CROPS
The GM genocide: Thousands of Indian farmers are committing suicide after using genetically modified crops.
''When Prince Charles claimed thousands of Indian farmers were killing themselves after using GM crops, he was branded a scaremonger. In fact, as this chilling dispatch reveals, it''s even WORSE than he feared.''

This can happen to USA, Canada, UK, Australia, South Africa, NZ etc ---------------GM SEED USE MUST BE STOPPED.---------------------

Indian Ministry of Agriculture..confirms ..a HUGE HUMANITARIAN CRISIS, more than 1,000 farmers kill themselves each month!!!!!!!!

Prince Charles is setting up a charity, the Bhumi Vardaan Foundation, to help those affected and promote organic Indian crops instead of GM. India''s farmers are also starting to fight back. As well as taking GM seed distributors hostage and staging mass protests, one state government is taking legal action against Monsanto for the exorbitant costs of GM seeds.

PLEASE READ and Tell Friends and Family- http://tinyurl.com/6ehp3z

[chloemontague]

STOP GM FOOD AND CROPS
The GM genocide: Thousands of Indian farmers are committing suicide after using genetically modified crops.
''When Prince Charles claimed thousands of Indian farmers were killing themselves after using GM crops, he was branded a scaremonger. In fact, as this chilling dispatch reveals, it''s even WORSE than he feared.''

This can happen to USA, Canada, UK, Australia, South Africa, NZ etc ---------------GM SEED USE MUST BE STOPPED.---------------------

Indian Ministry of Agriculture..confirms ..a HUGE HUMANITARIAN CRISIS, more than 1,000 farmers kill themselves each month!!!!!!!!

Prince Charles is setting up a charity, the Bhumi Vardaan Foundation, to help those affected and promote organic Indian crops instead of GM. India''s farmers are also starting to fight back. As well as taking GM seed distributors hostage and staging mass protests, one state government is taking legal action against Monsanto for the exorbitant costs of GM seeds.

PLEASE READ and Tell Friends and Family- http://tinyurl.com/6ehp3z

[drinuk]

This report is all about Big Pharma attempting to clear the shelves of all but what they want You to have. This country is BANKRUPT but we are yet to hear one of our paid employee''s, the politicians questioning or condemning these wicked crooks from ripping off our nation.

They are openly abetted by the FDA, politicians and by and large the whole of the medical profession. Obama or no Obama this country will shortly fall over, maybe then the people will go looking for these crooks who have committed a daily genocide against us.

Yes it is a mess, one which will get worse before getting better.

[barbaram99]

I am on medicaid and medicare and cos I have medicare ,medicaid won''t pay for my meds. Medicare part D does. I don''t trust every medication a doc writes as I feel they are unsafe. In America that can be true. I will ask is this the right med as they do make arrors. a mess it is.

[johnsole1]

What you need to know is that the FDA does not "test" anything. They do an exhaustive, off-point, and bureaucratically slow data review. You may ask, where does the data come from? It comes from the manufacturers, i.e. big Pharma, little Pharma, etc., who submit it in a format skewed for their product''s benefit. The data is totally biased and there is no counter-testing. The long-term real testing is what the trusting American public does every time we blindly suck down the meds, no questions asked. Why do you think the pharma manufacturers spend so much money on commercials? They want you to ask your doc about their product that has name recognition but no history. Your doc probably has mountains of free samples for any new, minimally tested, basically unregulated product.

[erasmus81]

Where I live, we TRUST our pharmacists. They know more about the drugs and what they do, than the doctors do.

We aren''t charged an arm and a leg for medications. The government regulates everything so they can''t take us for a ride. And they also make sure that whatever it says in that "bottle" is indeed in that bottle.

"Dozens of deaths have been linked to medications that have never been reviewed by the government for safety and effectiveness..."

This is pathetic.

[erasmus81]

Here is a perfect case. My medication for blood pressure at any WalMart is 4 dollars. If I order that same medication through my medical insurance company it cost me $100.00

Posted by A_witness at 03:17 PM : Nov 24, 2008

There is no question that you are being ripped of by your insurance companies, but I would also watch out for Walmart. I''ve heard they have quite a few "mix-ups".

[erasmus81]

However, the bottom line is that the fact no one has PROVED a drug works DOES NOT PROVE THAT IT DOESN%u2019T, much less that it is dangerous.

Posted by lf1952 at 02:02 PM : Nov 24, 2008

You need to forget that. The problem you should be worried about is whether or not the bottle acually contains the medication that is stated on the outside. It could be anything.

[a_witness-2009]

Here is a perfect case. My medication for blood pressure at any WalMart is 4 dollars. If I order that same medication through my medical insurance company it cost me $100.00, which is my co-pay. Why pay $100 for a $4.00 medicaion. What a rip off of the American public. Why are our tax dollars going to pay for illegals medications too. What up with that....

[a_witness-2009]

If American drug companies did not charge so much for their medications and their get rich schemes, maybe people would not be going to alternative markets for their medications. Personally, I get the same drugs from a trust worthy source in Mexico for about one forth to one third the price we pay here. I don''t blame folks for going to other markets. Maybe some year the Drug Companies will get the message, that we are not going to pay their high prices. I also, think Drug companies pay the FDA to drag their feet on medications trying to enter our markets; they don''t want competition and lower prices.

[andor3]

"Trust your health care provider to know all of the above. "

that is a recipe for disaster! Health care providers need the guidance of the FDA in deciding what medicines are prescribed to treat each condition, disease, or symptom. The FDA requires research studies and filters the results. But each patient should also be educated about any treatments prescribed. Doctors are busy, have a hard time staying current, and make frequent mistakes.

[lady_organs]

We have to save the social security system somehow liberals!

[lf1952]

PART 3 or 3
(3) NO DRUG IS 100% SAFE. Any drug can kill someone. Some drugs cut death rates in half, BUT may kill 1:50,000. Would you deprive the other 49,999 of having their chance of dying drop by 50% in order to avoid that one death???
Don''t look to the FDA to play doctor. NOT their job.

Drug safety studies can NEVER mimic the "post marketing experience" data (after drug released for general use). No drug study could randomize a million people. The MOST important thing the FDA does is to tract adverse reaction reports during that time and pick up dangerous trends. Sorry, that''s just the nature of science and statistics - which are the basis of drug research.

Now, again, the article is about OLD drugs (like aspirin) but which have always required prescriptions. I have been talking about new drugs or drugs used %u201Coff label%u201D. However, the bottom line is that the fact no one has PROVED a drug works DOES NOT PROVE THAT IT DOESN%u2019T, much less that it is dangerous. Just because the FDA has pulled a drug doesn%u2019t make it dangerous either %u2013 just says that they couldn%u2019t take the heat of admitting no such thing as a 100% safe drug! Trust the person who writes your prescriptions, and if you have questions, ASK! The FDA is already are causing enough trouble, holding important medications over tiny adverse reaction rates because they fear criticism (an approach I think is unconscionable). Trust your health care provider to know all of the above.

[erasmus81]

"THE FDA SHOULD BE DIS-MANTLED. IT IS USELESS!"

Posted by darnedsocks at 09:45 AM : Nov 24, 2008

I''m thinking EVERYTHING should be dis-mantled and started all over again.

Everything is a MESS.

[lf1952]

PART 2 or 3

(2) Getting FDA approval for an individual indication for a drug costs millions of dollars. There are NO laws that require a practitioner to only use a drug for FDA approved indications BECAUSE (a) the drug maker has to spend millions on research for EACH and EVERY indication, regardless if it is obvious the drug would work for something else - again, that''s why your health care practitioner went to medical school and reads current research. A classic example is clarithromycin (Biaxin) was the first drug of that class. You had to take 1 twice/day for 10 days. The company that made it paid for the research to provide it worked for acute sinus infection. Then came azithromycin (Zithromax) that you only have to take 2 a day for 3 days or 2 the first day, then 1 a day for four days, with less stomach problems. The maker of azithromycin didn''t bother to get an FDA indication for sinusitis - no reason to, it was obvious it would work for that (and it does). They just got indications for simpler to prove things.

Another example: urologists used alpha blocker blood pressure drugs to reduce prostate obstruction for almost a decade before someone paid to do the research for the FDA to approve those (blood pressure) drugs for that use. Now they are marketed as %u2018prostate%u2019 drugs and the blood pressure drop is a %u201Cside effect%u201D.

MORE TO COME

[lf1952]

PART 1 of 3

OK folks...let''s take a deep breath and take a few steps back:

The article is about OLD active ingredients that were grandfathered (everyone thought anyway). That would include aspirin, if it were prescription, BTW. Under current FDA rules, I am NOT confident aspirin would be approved today, despite the fact it stops headaches, treats rheumatoid arthritis AND prevents heart attacks.

However, many of the previous comments go further and let me discuss those.

The FDA has become very nervous about criticism, rather standing up and explaining reality. For example, the recent %u201CBlack Box%u201D warnings about Fluoroquinolones are NOT anything new %u2013 we have known that they VERY rarely can cause tendon rupture (we still don%u2019t know how), but their value, effectiveness, lack of frequent side effects made that essentially a non-issue. In 28 years of practice, I have seen exactly ONE patient who had a tendon rupture %u2013 not my Rx %u2013 and I have written hundreds (or more) quinolone Rx%u2019s. NOW, all of a sudden, it%u2019s a %u201CBLACK BOX%u201D warning%u2026.nothing changed, the FDA has gotten defensive.

So:

(1) The practitioner who writes the prescription is the one responsible for deciding if the drug is appropriate for you, NOT the FDA (or anyone else). YOU and the person writing the Rx must communicate. I never write an Rx that I don%u2019t tell the patient what SHOULD happen, and what SHOULD NOT happen. YOU should expect that.

MORE TO FOLLOW

[jsd330]

Whose minding the store? Must be the executives from the banks and the big three.

[walt1944-2009]

As has been suspected for years, it has been learned that the drug companies have been using the average patient as a "test mouse" by handing out unapproved and/or experimental drugs and letting the average consumer "test" them.

This is simply another example of the philosphy of the Great Emperor Bush II and all neocon Fascist Nazi Republicans which is simply put "I CHEAT ''EM AND HOW!!!"! Inspired by the example of the Great Emperor Bush II and his neocon Fascist Nazi court, Corporate America has followed the same philosphy discovering a new avenue to generate even greater PROFITS!

So now there is no need to run products thru special testing groups or to have medicines tested by the FDA (which is run by allies of the Great Emperor anyway!), when Corporate America can make available any JUNK or POISON to the average consumer of the USSA, and not have to fear any repercussions from it!!!

SIG HEIL, I CALL MY GANG THE "HOLE IN THE WALLET" GANG!!!, BUSH!!!

[puzzler125]

The FDA is one more thing for President-elect Obama to fix. Actually? I think he''ll fix far more than his predecessors!