There’s little doubt that the pharmaceutical industry has brought many life-saving medications to people throughout the world. Unfortunately, this industry also has a dark side. Big Pharma’s relentless search for ever-increasing profits has betrayed many who were vulnerable and seriously ill.
The Plot: Destroying Cancer Drugs in Order to Raise the Price
In a James Bond movie, you’d expect the villain to concoct an evil plot to destroy sick children’s cancer drugs, creating an artificial shortage and raising prices by 4,000%. This may sound like fiction but it actually happened.
The bombshell report by The Times revealed that Aspen Pharmacare, a huge South African drug company, became embroiled in an argument with the Spanish health service in 2014. According to the company’s own internal emails, plans were in place to destroy life-saving cancer drugs rather than ship the drugs to Spain at the contracted price. To the company, this was only a tough negotiating tactic to raise prices. Without their drug shipments, Spanish cancer patients would be forced to obtain drugs elsewhere at much higher prices.
A number of critical drugs were included in this scheme including:
- Mercaptopurine, used to treat children suffering from acute lymphoblastic leukemia
- Busulfan, a treatment for leukemia patients
- Chlorambucil, a blood cancer drug
- Various medications used to treat elderly cancer patients
It was subsequently revealed that Aspen had also used similar tactics against other European nations.
- Aspen threatened Italy with a halt in drug shipments if they did not agree to pay 2,100% more within three months.
- Germany, Belgium and Greece were also faced with a similar threat.
The Price Impact of Increased Drug Prices
Constantly increasing drug prices are a serious problem for many people worldwide. In America, many patients, especially the elderly on fixed incomes, find it necessary to buy lower-priced prescription medications from Canada, India and elsewhere. Health insurance plans change their coverage for drugs and medical treatments every year. Many patients are forced to make very difficult decisions.
In the U.K. and Wales, there were astronomical price increases on many badly needed drugs in 2013.
- Busulfan, a leukemia drug, had a price increase from £5.20 to £65.22.
- Leukeran, another leukemia drug, had a 400% price increase.
- Melphalan (Alkeran), used to treat skin and ovarian cancers, had a similar price spike.
- Generic cancer drug price increases cost the UK’s National Health Service an extra £380 million.
A Shocking Email
Big Pharma is often portrayed as unfeeling and concerned only with profits. Is this opinion justified? The Times printed a confidential email in which an Aspen employee jubilantly reported signing new price and reimbursement agreements which were in accord with European price targets. The employee concluded by saying, “Leukeran, a bit higher! … Let’s celebrate!” That statement says it all.
Big Pharma, the FDA and the Law
Unless your kid has Duchenne muscular dystrophy, you may have never heard of deflazacort. This is a steroid that has been used for many years for MS patients worldwide because it has fewer side effects than other steroids. In the US, this drug was often obtained from suppliers in Europe or Canada at an affordable yearly cost of $1-2,000.
In the U.S., patients were buying deflazacort elsewhere because the Food and Drug Administration (FDA) had never approved the drug for sale in the U.S. This has happened before with older and inexpensive drugs. No pharmaceutical company had ever decided to go through the expensive and lengthy FDA approval process for deflazacort because the drug sold at too low a price to make it worth their while.
Big Pharma has a solution to this problem – turn an old drug into a new one. Marathon Pharmaceuticals went through the FDA’s approval process for deflazacort, renamed to Emflaza. The FDA considers any newly-approved drug to be a new drug even if it has been used successfully for many years. Emflaza, the new version of deflazacort, was put on the market for a new price – $89,000. That was a whopping 6,000% jump in price.
Drug companies don’t only benefit by being able to escalate the price of an inexpensive, well-known older drug. They also benefit from laws passed to encourage the development of new drugs for rare diseases.
Drug companies receive valuable benefits for a newly-approved drug.
- The Orphan Drug Act provides manufacturers with a 7 year monopoly on the drug.
- Companies can jumpstart fast FDA approval for their next drug by means of a rare disease priority review voucher. These vouchers are extremely valuable and can be sold for very high prices.
The FDA, Big Pharma and Colchicine
A similar situation happened with colchicine, an inexpensive drug used for centuries throughout the world to prevent crippling and painful gout attacks. Colchicine had been used successfully for gout long before the FDA came into existence. For years, gout patients in the U.S. were able to purchase colchicine for about 10 cents a pill because the drug had been “grandfathered” by the FDA.
In 2006, the FDA decided that all “grandfathered” drugs should go through the official approval process. In 2009, URL Pharma, a Japanese firm, took advantage of the loophole in the law and turned the inexpensive old drug colchicine into the very costly Colcrys. Pills that used to cost 10 cents were now selling for $5.00 each.
Big Pharma Continues to Cash In
In the U.S. and Europe, it’s apparent that money speaks much louder than the health needs of patients. People are justifiably outraged about unreasonably high drug costs but receive only a lot of words and few actions from legislators.
There isn’t an easy solution for exorbitant drug prices, but one approach is to elect individuals who understand the problem. Insist that legal loopholes be closed. Prosecute law-breakers. Above all, make others aware of the reprehensible behavior of Big Pharma. As long as the general public remains silent and unaware, the problem will continue.