A Colorado psychiatrist and talk show host has been warning people that generic drugs from some foreign sources are having dangerous reactions in patients due to lack quality control standards by manufacturers.
Dr. Russell Johnson, a psychiatrist in Greeley, Colorado along with his business partner Jeff Huff hosts a weekly two hour show, Shrink Rap on 1310 KFKA.
Johnson told the Gazette over the past several years they have noticed a quality problem with generic drugs coming from overseas.
“We’ve had significant quality issues primarily with generic drugs manufactured in India and the former eastern bloc countries,” Johnson said. “They are a significant portion of the market now and we’ve had trouble with nearly all of the major manufacturers when it comes to psychiatric drugs from these countries.”
While the news of contaminated drugs may come as a shock to Americans, the Food and Drug Administration has apparently been aware of the issue for some time.
The American Enterprise Institute reported that the FDA is concerned about foreign countries falsifying data about the quality of the drugs they produce.
According to AEI, the International Pharmaceutical Quality noted that “Over the past year, the US Food and Drug Administration (FDA) reported that foreign producers of drugs were increasingly falsifying data about the quality of medicines, and the FDA issued six warning letters to companies in Mexico, Poland, the United Arab Emirates, India, and Canada about the quality of active pharmaceutical ingredients, over-the-counter solutions, and injectibles.”
AEI noted that while the companies initially receive FDA approval for quality, after receiving the certification foreign companies, particularly in India are tempted to sacrifice quality in order to lower costs.
“Indian producers in particular strive to reduce costs by substituting cheaper ingredients or skimping on good manufacturing practice, and often patients and well-informed pharmacists alike will overlook the flaws,” the AEI story said.
Johnson explained that they have generally do not have the same quality issues with medications manufactured in North America, Israel or Western Europe. Instead, the primary problem is more recent generics manufactured in the last six or seven years from countries like India.
“Over the last six or seven years we’ve been seeing Indian manufacturers dominating the market. This coincides with what we have been seeing. Things that have been generic for 10 years or more we’ve had very little problem with. The problems we are having primarily have to do with drugs that have gone generic in the past six or seven years.”
The drugs in question include many well-known and prescribed drugs such as Celexa and Zyprexa, however, Johnson says they have seen the problems in all of the drugs they prescribe.
“We have seen it with nearly all the anti-seizure medications that we use for mood stabilization. There have been cases where a person is doing very well and has been stable for years and suddenly gets switched to medications from one of these countries and begins to feel like they did before they ever went on the medication.”
“We’ve had over 1,000 patients who have gotten worse on some of these generics over the last six or seven years,” Johnson explained. “We first noticed it when Celexa went generic around Thanksgiving of 2006 and we stopped counting when we had over 150 people having problems with it by March of 2007.”
The FDA has been aware of the problem for some time. In 2008 the agency issued an import alert that banned the import of 28 types of generic drugs produced by Ranbaxy Laboratories in India. The company is one of the largest suppliers of generic drugs to the United States.
The alert covered common generic medications such as pravastatin and simvastatin which are used for high cholesterol as well as other drugs used to treat type 2 diabetes and high blood pressure.
While the FDA said they were concerned about quality standards, they did not order any Ranbaxy drugs removed from pharmacies saying they believed they met FDA standards.
In announcing the ban, Deborah Autor, director of the office of compliance at the Center for Drug Evaluation said, “all the products we have tested met specifications” and the government wanted to reassure consumers there was “no reason” to consider them hazardous.
Johnson said while the government may say the drugs meet specifications, the problem is generic drugs are held to a less stringent standard than brand name medications.
“To get FDA approval a company manufacturing a generic drug has to prove they can come within 25% of the labeled amount of medication in the pill and that if a healthy volunteer takes the medication they can find it in their bloodstream within acceptable limits,” he explained. “If a 200 mg pill contains between 160 and 250 mg of the medication it is acceptable according to the FDA standards. By contrast brand-name drugs only have a 5% leeway.”
Johnson blames the problem on the push by the government and insurance companies towards generic versions of brand name drugs.
“It’s not just the government pushing generics, the insurance companies obviously want it. The pharmacies also like it because some of the generics have a much higher profit margin than the brand-name drugs. AARP is also pushing to have more drugs be offered in generics in order to be cheaper and faster. Unfortunately, just like in any other industry cheaper is not always better.”
While defective drugs are problematic for everybody taking medication, Johnson says the effects are particularly noticeable for the patients he sees as well as neurology patients.
“If you’re prescribing an anti-cholesterol or anti-coagulant drug you might not notice the effects if it is not working properly for quite a while, but the neurologists and psychiatrists are picking up on this much faster. There’ve been instances where seizure patients were given drugs from a different manufacturer and they began to have seizures again.”
“People on antidepressants will feel the effects rather quickly that they get something that’s not working like it is supposed to. Most of the media buy into the assertion that everything that is FDA approved is equally effective, but often the generic drugs are not tested for safety or effectiveness.”
According to Johnson, the problem is oftentimes patients may not have any choice but to get their drugs from India.
“We can specify on the prescription form which manufacturer we prefer, but that doesn’t always happen. We were talking on the radio show Saturday about how someone had brought us a bottle from a local pharmacy and his prescription said ‘Teva only,’ which is an Israeli company. In spite of this the pharmacy dispensed a medicine from an Indian manufacturer.”
He explained that the problem is not necessarily the pharmacist’s fault.
“In many cases the pharmacies can’t get anything from their wholesalers that isn’t from India. The local pharmacies have some autonomy in some cases, but other times they can only get what their wholesalers are carrying and more and more the time it is almost exclusively generics from India.”
In 2012, Rep. John Dingell, D-Michigan, wrote a column for CNN warning of the possible dangers from generic drugs from China and India. Dingell sits on the House Committee on Energy and Commerce, which oversees the FDA.
“What most Americans don’t realize is the staggering fact that the number of drug products manufactured outside the United States has doubled between 2001 and 2008,” Dingell said. “Nearly 40% of all drugs taken by Americans come from overseas, and nearly 80% of the active pharmaceutical ingredients used to make these drugs also come from foreign countries — mainly China and India.”
He went on to say that many of the drug manufacturing plants overseas have never been inspected, despite their providing large amounts of drugs to American consumers.
“Domestic pharmaceutical facilities are inspected, on average, every two years by the FDA, whereas foreign drug facilities are inspected only every nine years. According to the Government Accountability Office, some of the 3,765 foreign drug establishments in the FDA’s database may never have been inspected.”
Dingell has proposed a “global FDA to ensure safety and level the playing field for American manufacturers.
Part of the problem is that FDA inspections of foreign plants are few and far between. In India and China the inspections average once a decade, compared to every two years for domestic companies.
AEI noted that unlike in America, the inspectors are not given unfettered access to the plants. Additionally, plant managers who are given several days’ notice of the inspectors arrival often have time to cover up quality issues until after the inspectors have left.
Johnson said the issue is especially important when one considers the recent mass shootings by individuals with mental health issues as congress and state legislatures debate gun control.
“Because of privacy laws we have no way of knowing whether these people were taking medication that didn’t work,” he said. “In most cases they probably were never on medication or if they were they stopped taking it. However, it is just a matter of time before we have somebody who is taking their medication regularly, but ends up getting their prescription from India or one of the other countries and as a result goes off and does something like we saw in Sandy Hook.”
“Unfortunately, only then will Congress probably decide to deal with this issue. I can’t see it happening before then.”