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Disposing of unused prescription and over the counter drugs including antibiotics, antidepressants, anticonvulsants and birth control pills by dumping them down the toilet has contaminated the drinking water supply for 41 million Americans. Further, unused prescription drugs stockpiled in medicine cabinets can contribute to drug abuse or overdoses by children, teens and adults. Currently, there are no guidelines or regulations in place to deal with the safe disposal of unused consumer medicines and drugs.

According to a post on today’s Pharmalot blog, a Washington State senator is introducing legislation (for the fourth time) to develop an environmental safe plan to dispose of unused and potentially harmful medications. The plan calls for dropping off unused medicines at local pharmacies; a service that would be underwritten by the pharmaceutical companies who manufacture the drugs. And, wouldn’t you know it, PhRMA, the pharmaceutical industry trade groups is lobbying and fighting against the legislation for the fourth time. In addition to PhRMA, the Consumer Health Products Associations which represents manufacturers of over-the-counter drug and the Washington Biotechnology and Biomedical Association are fighting the proposed legislation. Some municipalities like the City of Puyallup, WA allow persons to dispose of prescription medications including cancer treatments, painkillers, antidepressants and statins in lock boxes in the hallway of the local police department. However, these municipalities are the exception not the norm.

The groups opposing the legislation contend that regulations are unnecessary because contaminating drugs found in drinking water results not from improper disposal practices but through urination and defecation. In fact, they contend that the best way to dispose of unused medicines is in the household trash. But what about leeching of these drugs from landfills into aquifers and other sources of drinking water you ask? And what about dealing with potential drug abuse and sale of illegal prescription drugs? 

Interestingly, I had some minor surgery last week that required some pain medication and as I was rummaging through my medicine cabinet, I found a at least eight bottles of pain medication prescribed for various family members dating back to 1999. I thought about getting rid of the expired pills, but I had no idea about what the best disposal method may be. Consequently, the pill collection is still taking up space in my medicine cabinet. And, with two teenagers in the house, I am starting to get a little anxious! 

That said, it makes perfect sense to me that there ought to be regulations guiding the disposal of drugs in the US. And, because drug manufacturers have made huge profits on their products, I see no reason why drugmakers should not support and help to underwrite programs to safely dispose of unused prescription and over-the-counter medications. Maybe people’s negative impression of big pharma would improve if the powers at be would just suck it up for once and pay to help to solve problems that helped to create!

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

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Mark Senak, author of the incisive EyeonFDA blog and de facto watchdog of all things social media in the life sciences, has assiduously been tracking company and trade organization input to the docket for the Part 15 meeting on medical product promotion and the internet and social media. To date, according to Mark, the following companies and trade groups have officially submitted their comments and viewpoints to the docket                                                                                              

1. Covidien
2. Johnson & Johnson
3. Bayer Healthcare
4. Sanofi Aventis
5. AstraZeneca
6. Eli Lilly
7. Medtronic
8. Pfizer
9. Abbott
10. Novartis
11. Genentech
12. Sepracor
13. Merck
14. Medtronic
15. Biotechnology Industry Organization (BIO)
16. PhRMA
17. National Organization for Rare Disorders (NORD)

As you may recall, industry input was lacking and surprisingly absent from the public hearings held by FDA on the topic earlier this year. While news analysts and bloggers were incredulous that companies didn’t actively participate in the earlier public hearings, this behavior is typical of life sciences companies that like to do things quietly and, when possible, behind closed doors. Ironically, this lack of transparency and inclination to secrecy is the antithesis of social media. Is it any wonder then, that life sciences companies are suspicious and wary of the impact that social media may have on their ability to conduct business?

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

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Billy Tauzin, a former Congressman and high profile lobbyist, unexpectedly resigned as President of the Pharmaceutical Research and Manufacturers of America, (PhRMA), a pharmaceutical industry lobby and trade organization. According to a report in today’s New York Times, his resignation resulted from internal disputes over PhRMA’s pact with the White House to trade political support for favorable terms in the proposed health care reform bill. The trade group issued a news release on Thursday night confirming Mr. Tauzin’s departure, effective June 30.

When he first took the helm at PhRMA in 2005, Tauzin’s publicly-stated goal was to improve the group’s image and reduce the “number of its enemies.” Prior to Tauzin’s arrival at PhRMA, it was an obscure lobbying group that was little more than a “rubber stamp” for the agenda set by pharmaceutical companies. Under Tauzin's tutelage, the trade group adopted a more progressive strategy and tried to set a new agenda for the pharmaceutical industry.

In exchange for favorable terms in the original Obama healthcare reform package, PhRMA spent more than $100 million on ads to promote the overhaul. But after healthcare reform stalled, some industry leaders felt the trade group had gone too far giving concessions and could lose on some important legislative issues without gaining the political protection it had sought.

Despite publicly accusing the White House of reneging on its original deal, Tauzin’s willingness and zeal to help to reform healthcare ultimately led to his demise. I suspect that the next person chosen to lead PhRMA will likely be a pharma insider willing to "tow the party line."  While I wasn’t originally keen on Tauzin’s appointment, he proved to be an extremely effective  leader, who unlike most of his PhRMA predecessors, was forward-thinking and had a clear vision for the future of an industry currently in transition.

Tauzin’s departure signals that many pharma executives believe that healthcare reform is dead and companies can continue with “business as usual.” While failed healthcare reform may be beneficial to big pharma in the short term, it ultimately may lead to pharmaceutical price control legislation. This is because—in the absence of healthcare reform— drug and devices prices will continue to skyrocket and  legislators will have little choice but to regulate and cap drug and devices prices.

Until next time,

Good Luck and Good Job Hunting!!!!!!!

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Much has been written about how supportive the pharmaceutical industry has been about US healthcare reform. Prior to the debate, the Obama administration gleefully announced that pharma will give $80 billion in drug discounts in exchange for certain assurances that weren’t publicly disclosed. As most of us know, the US House of Representatives passed historic healthcare reform legislation last week and in addition to a public option it stipulates that pharma will be required to give $140 billion in drug discounts. According to Ed Silverman over at the newly reinstated Pharmalot blog, AstraZeneca CEO David Brennan, who is also this year’s chair of the industry trade group PhRMA, vowed that pharma would fight the house healthcare reform legislation. 

While Brennan’s statement isn’t surprising nor particularly noteworthy, his comments explaining pharma’s position on healthcare reform are revealing and important to understand. He told the Huffington Post “We said there were principles we didn’t want to see violated. And if those principles - price controls, Medicare rebates, moving dual eligibles back from Medicare and back into the Medicaid discount program - if those things happen, I can’t see how we could be supportive of the program.” In other words, we will support anything you propose— and may even be willing to kick in another $60 billion or so to support healthcare reform— but any discussion about government regulation of drug prices is a deal breaker! 

To my knowledge, this is the first public mention of price controls by any pharmaceutical executive during the almost year long debate on healthcare reform. The reason that I find Brennan’s statement interesting is that I have long contended that pharma will give the Obama administration and Congress anything it wants in exchange for assurances that the government will not attempt to control drug prices. For those of you who don’t know, the US is one of the only countries in the world where the government is prohibited from setting drug prices. This means that US drug makers in concert with insurance companies and third party payors can set drug prices based on what the American pharmaceutical market can bear. Not surprisingly, the profit margins on drugs sold in the US are the highest in the world. Obviously, pharma doesn’t want the US government hindering or limiting their profits by setting or capping drug prices. 

I am glad that pharma has finally decided to publicly “come clean” on the price control issue. The public option and issues surrounding data exclusivity for follow-on biologics pale in comparison to the financial havoc that price controls would wreak on the pharmaceutical industry. And, I suspect that pharma and its lobbyists will do whatever it takes to insure that price controls never become a reality in the US. However, at the end of the day, government regulation of drug and device prices will ultimately be required for any meaningful changes to take place to the US healthcare system.

Hat tip to Ed!

Until next time...

Good Luck and Good Job Hunting!!!!!!!

Addendum: After writing this post this weekend, an article appeared in Monday's New York Times that revealed that the drug industry has quietly been raising its wholesale prices on prescription drugs over the past year.  This, of course, was done in anticipation of possible federal legislation that might impose some government controls on drug pricing.  According to the Times article: "In the last year, the industry has raised the wholesale prices of brand-name prescription drugs by about 9 percent, according to industry analysts. That will add more than $10 billion to the nation’s drug bill, which is on track to exceed $300 billion this year. By at least one analysis, it is the highest annual rate of inflation for drug prices since 1992. The drug trend is distinctly at odds with the direction of the Consumer Price Index, which has fallen by 1.3 percent in the last year.  Not surprisingly, the US pharmaceutical industry justifies the practice because as an industry spokesperson put it  "they are having to raise prices to maintain the profits necessary to invest in research and development of new drugs as the patents on many of their most popular drugs are set to expire over the next few years."  Hmmmm, interesting comment considering the US pharmaceutical industry has layed off over 180,000 employees over the past three years, a majority of whom are R&D scientists...go figure!

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There was an interesting post today at the Seattle, WA-based  Xconomy.com website about the salaries of people who work in the biotechnology industry. The post mainly focused on the salaries of biotech workers in the Pacific Northwest and based on results of a local survey the median salary is roughly around $60,000 per year. While this pales in comparison to the $81,499 reported earlier this spring from a group sponsored by the Pharmaceutical Research and Manufacturers Association (PhRMA), it is important to note that “real salary” data are difficult to obtain and much of what is released is based on salary figures that don’t include bonuses and other benefits. Further differences survey methodologies may also account for the seemingly disparate results. Nevertheless, salaries in biotech are generally better than those offered in other science-related industries and, not surprisingly, are highly dependent on degree requirements and job duties and responsibilities.

The bottom line: in my opinion, a job in biotech is a good career choice because of the projected upward growth for the industry. More importantly, pharma is continuing to abandon its reliance on small molecules and increasingly embracing biotechnology and its products as the future of the life sciences and healthcare industries. If I was undergraduate life sciences major today, I would be looking to the biotech and medical devices/devices industry, not pharma, for future long term employment!!! And, contrary to popular belief, a PhD degree is no longer a requirement for many biotechnology jobs.

Until next time...

Good Luck and Good Job Hunting!!!!!!

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According to a recent report issued by the Pharmaceutical Manufacturers of America (PhRMA), a record 861 new cancer treatments are being developed by pharmaceutical and biotechnology companies. Many of these treatments, which include vaccines and immunomodulators, are in clinical development or awaiting regulatory approval.

The breakdown of the treatments based on therapeutic areas is: 122 for lung cancer, 107 for breast cancer, 70 for colorectal cancer and 103 for prostate cancer. Additional treatments target brain, kidney, pancreatic and other forms of cancer.

While there are many other unmet medical needs that must be addressed by the life sciences industry, the burgeoning and ever-increasing numbers of cancer patients suggests that there is a dire need for development of improved anti-cancer treatments. To that end, if you are contemplating graduate school, already enrolled or trying to determine what therapeutic area makes sense for a postdoctoral fellowship, I highly recommend that you consider oncology. Job opportunities in this field (and neuroscience) will continue to outstrip all others in the near future.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!
 

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Word on the street suggests that Roche has severed its relationship with the Pharmaceutical Manufacturers of America (PhRMA) the trade group that represents and lobbies on behalf of the pharmaceutical industry. The recent purchase of Genentech must have convinced the venerable 100 year old pharmaceutical company that proteins not small molecule drugs are the key to its future.

According to published reports, the Biotechnology Industry Organization (BIO) has already sent an emissary to Roche's headquarters in Basel to talk to Severin Schwan, its CEO, about the benefits of BIO membership. Will Roche really eschew its membership in RhRMA and join BIO? And,will the loss of Roche's financial contributions substantial reduce PhRMA's influence and lobbying power in Congress? I guess only time will tell!

 Until next time...

 Good Luck and Good Job Hunting!!!!!!

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Previously, the US Congress proposed legislation to create a regulatory approval process to allow the Food and Drug Administration (FDA) to approve generic versions of blockbuster biotechnology drugs known as follow-on biologics (FOBs). While a regulatory pathway exists for approval of generic versions of small molecule drugs (as outlined in the Hatch-Waxman Act) there is no legally-approved regulatory pathway to bring FOBs to market in the US. In contrast with the US, the European Union crafted legislation five years ago that allows biosimilars —the name given to FOBs in Europe—to be approved and sold in EU member states. Since 2004, the European Medicines Agency (EMEA), the EU regulatory body, has approved the sale of six biosimilar drugs with many more in the queue awaiting regulatory review.

The debate over FOB legislation started in the US about 10 years ago when patent expiry of many  multi-billion blockbuster biotechnology drugs was fast approaching. From the beginning, many so-called innovator companies (the companies that produced the original branded biotechnology drugs) and the trade associations that represent them on Capital Hill, the Biotechnology Industry Organization (BIO) and the Pharmaceutical Manufacturing Association (PhRMA), aggressively lobbied against any form of FOB legislation. However, late last year, several senators introduced legislation that would permit FDA to approve generic versions of many blockbuster biopharmaceutical products following patent expiry. The proposed legislation stipulated that FOB manufacturers would have to wait 12 years —after patent expiry of previously approved biotechnology drugs—before generic versions of those drugs could be sold in the US. That legislation, which unabashedly favored innovator drug manufacturers, passed the Senate health committee but died without being voted on. The new measure, introduced Thursday, cuts by more than half — to 5 years, from 12 — the time allowed before cheaper versions of biotechnology drugs could compete with the originals. A similar bill was introduced two weeks ago in the House by Representative Henry A. Waxman, Democrat of California and chairman of the Energy and Commerce Committee.

While the proposed reduction in the so-called “FOB waiting period” is commendable, I don’t think that any waiting period is necessary before FOBs can be sold in the US. It is difficult to understand why innovator companies require an additional patent protection—beyond the 20 years already afforded to them under US patent law—to continue to sell their blockbuster products! To that end, Jeff Joseph, a spokesman for the BIO said that the FOB waiting period reduction, “.... Would jeopardize patient safety and undermine our ability to develop future cures and therapies.” I believe that the FOB waiting period being championed by innovators companies is nothing more a thinly veiled attempt by them to continue to maintain monopolistic control over lucrative multibillion dollar biopharmaceutical drug franchises. Biotech executives have vowed to vigorously fight the new legislation, saying it could result in unsafe medicines, fewer cures and fewer jobs in biotechnology centers like Boston, California and elsewhere. Interestingly, similar arguments were put forward by the pharmaceutical industry before the Hatch-Waxman act was passed by Congress in 1984..

Despite the claims that FOBs will stifle innovation and may jeopardize the safety of Americans, the current high costs and lack of access to affordable healthcare will almost certainly leave Congress no choice but to pass legislation that permits the marketing and sale of FOBs in the US. While FOB legislation is a likely fait accompli, US drug manufacturers remain steadfastly opposed to any FOB legislation. I believe that innovator company opposition to FOB legislation is really a “red herring” that serves to detract attention away from the real issue that the drug industry is deathly afraid of federal regulation of drug prices. Interestingly, the US is one of the only countries in the world where drug prices are not regulated or controlled by the government. This permits drug manufacturers to set prices based exclusively on “what price the US market will bear.” In other words, they can charge as much as they want for their drugs, as long as third party payors, insurance companies and Medicare and Medicaid agree to continue to cover the costs of the drugs that they manufacture (it should come as no surprise to anyone that the American pharmaceutical and biotechnology markets are the largest and most financially lucrative in the world).

I have no doubt that innovator companies will continue to fight hard and as long as possible prevent adoption of legislation regulating the approval of FOBs. After all, there are huge sums of money and corporate profits at stake. Like it or not, FOBs will ultimately be sold in the US—the current costs of drug and healthcare are simply too high to sustain. Despite a fierce decade-long struggle, most American drug makers will privately concede that sale of FOBs in the US is inevitable. Nevertheless, innovator companies will likely not publicly endorse FOB legislation until the US government provides them with assurances that it will not seek to regulate American drug prices for the foreseeable future.

Until next time...

Good Luck and Good Job Hunting!!!!!!

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Just when I thought the absurdities surrounding the American follow-on biologics debate couldn’t get any sillier, the US Federal Trade Commission (FTC) announced today that it would sponsor public workshops and round table discussion to learn more about the impact of follow-on biologics on American competitiveness, regulatory policies and healthcare costs.

I am not certain what role the FTC has in the follow-on biologics debate (as far as I am concerned, it shouldn’t have much of one) but what new information does the FTC think that it is going to get that other more relevant government agencies like FDA or the US Congress don’t already have about follow-on biologics? After all, the debate to formulate an approval pathway for follow-on biologics in the US has gone on for almost 10 years now. How ineffectual and ineffective can the US government and its agencies be (rhetorical question)?

As far as I can ascertain, the main reason why follow-on biologics are not already being sold in the US are the never-ending efforts of power, well-funded lobby organizations like BIO and PhRMA. The data are incontrovertible: 1) the cost of branded drugs is out of reach for many Americans, 2) access to potentially life-saving drugs and treatments is hindered by restrictive drug formularies and onerous insurance co-pays and 3) many local and state governments and large, multi-national corporations can no longer provide adequate healthcare coverage for their employees because of out-of-control medical costs and expenditures.

In my opinion, the irony of the US follow-on biologics brouhaha is that it is putting American companies at a competitive disadvantage in the biosimilar/follow-on biologics space. Selling profitable, cheaper generic versions of blockbuster drugs is no longer a dream but a reality in countries like China and India whose middle class has finally come of age. True, the American pharmaceutical/biotech market is still the largest in the world—but will it still be the largest 10 years from now? Only time (and Asia) will tell.

Until next time….

Good Luck and Good Job Hunting!!!!!!!!

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Last year was a banner year for the pharmaceutical lobby (the largest in Washington DC). It spent over $168 million to inform Congress about issues that its members thought were in the best interest of the pharmaceutical and biotechnology industries. So what were the main issues that occupied a majority of the lobby’s time?

• blocking the importation of inexpensive drugs from other countries
• protecting pharmaceutical patents both within the United States and abroad
• ensuring greater market access for pharmaceutical companies in international free trade agreements

You are probably wondering which company was the top spender—it was Amgen! As you may recall, Amgen’s EPO franchise was under intense medical, regulatory and congressional scrutiny because of safety issue that resulted from over prescription. In my limited understanding of how things work in Washington, I have been told by lobbyist friends of mine that there is no better way to solve nagging problems than by paying influence peddlers to make them go away.  That said, Amgen’s lobbying costs paled in comparison with the $23 million spent by Pharmaceutical Research and Manufacturers of America a pharmaceutical industry trade group.  You Go PhRMA!!!!

A quick perusal of the top lobbying list reveals that all major US pharmaceutical companies invested heavily to influence members of Congress to allow them to preserve their stranglehold on the American healthcare system. Not surprisingly, all of the major foreign pharmaceutical manufacturers were also on list.  Much to my surprise, Teva, the Israeli generic manufacturing giant made the list this year—so it goes!

I guess altruism is out and avarice is still in! Hat tip to Pharmalot.

Until next time….

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